Cardiovascular Health

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93 Cardiovascular Health Trials Near You

Power is an online platform that helps thousands of Cardiovascular Health patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
To determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

100 Participants Needed

Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male

340 Participants Needed

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

72 Participants Needed

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

6618 Participants Needed

The goal of this study is to collect quantitative and qualitative data that can be used to optimize the HeartSteps mHealth intervention for physical activity. The current version of the intervention is intended to help patients with heart disease increase and maintain their physical activity long-term. To accomplish this goal, a 3-month pilot micro-randomized trial (MRT) will be conducted with 60 patients who are currently completing or have recently completed phase II cardiac rehabilitation (CR). The core of the study participation is the use of the HeartSteps intervention over the course of 3 months. This includes wearing the Fitbit Charge activity tracker during waking hours and using the HeartSteps intervention to support their efforts to be active. The HeartSteps intervention consists of two sets of intervention components: (1) components intended to improve participants' affective associations with physical activity, including activity suggestions designed to to trigger positive feelings and associate them with being active, and prompts to bring their awareness to intrinsically motivating aspects of being active; and (2) components that target reflective self-regulatory processes, including graphs for self-monitoring, prompts to plan activity, and weekly activity goals. How exactly, and how much, participants will use HeartSteps will not be prescribed since our goal is to understand naturalistic trajectory of engagement with the intervention.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

60 Participants Needed

Brain Stimulation for Stress

Pittsburgh, Pennsylvania
Investigators are conducting this study to test if temporarily and non-invasively stimulating the brain will affect the emotional response to stress in healthy participants. Participants will perform a series of tasks while completing an MRI scan. After this, participants will be randomized to undergo transcranial magnetic stimulation (TMS) at two visits, undergoing active stimulation at one visit and undergoing 'sham' stimulation at another visit. Immediately following both stimulation sessions, participants will repeat the tasks during MRI scanning.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 50

55 Participants Needed

Brief Summary: Black adults have a higher incidence of hypertension (HTN) and a greater risk of HTN-related cardiovascular disease (CVD) compared with White adults. Even mild elevations in blood (BP) above 115/75 mm Hg are associated with increased CVD risk. Accordingly, emphasis is being placed on early interventions for high BP, particularly in those who are low cardiovascular risk(systolic BP 110-139 and diastolic BP \< 90 mm Hg), for participants lifestyle modification is recommended. Although lifestyle modifications are effective to lower BP, implementation is suboptimal in Black communities, especially those participants residing in low-income urban settings. Pervasive negative social determinants of health (SDoH), such as poor access to healthcare, food insecurity, limited availability of healthy foods, lack of safe places to engage in physical activity, and low health literacy are major drivers of inequities in HTN and a critical barrier to implementation of recommended lifestyle modifications in Black communities. To achieve health equity, effective strategies must address negative SDoH that are root causes of racial disparities in health outcomes as clearly demonstrated by the coronavirus disease (COVID-19) pandemic. Predominantly Black cities like Detroit, Michigan, where the mortality rate from heart disease is nearly twice the national average, have been devastated by COVID-19. To address this, the investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct deployment of testing and vaccination services to communities with highest needs. Since April 2020, the investigators conducted 500 events with 220 community partners where 40,000 people have been tested or vaccinated for COVID in MHUs. Using a hybrid type I effectiveness-implementation design in the proposed Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study, the investigators will implement a novel approach that links low cardiovascular risk Black adult participants without stage-2 hypertension to collaborative care delivered in deprived neighborhoods by community health workers (CHWs) using a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention. The investigators will leverage our MHU program, layering on top of existing services to streamline access for screening, recruitment and all ongoing follow-up throughout the study period. Our specific aims are: AIM 1: To compare the effect of PAL2 intervention versus usual care (MHU engagement without PAL2) on systolic BP reduction and prevention of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP \>90 mm Hg) among 500 Black adults with baseline untreated systolic BPs below stage 2 (ranging 110-139 mm Hg) and a diastolic BP \< 90 mm Hg. Hypothesis (H) 1a: Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months. H1b: Diastolic BP levels and the incidence of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP \>90 mmm Hg) at 6 and 12 months (secondary outcomes) will be lower in participants randomized to the PAL2 intervention versus usual care. AIM 2: To use the RE-AIM framework to assess the reach, adoption, effectiveness, sustainability and cost of LEAP-HTN at 12 months post-randomization. H2a: The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and up to 24 months in subjects with available data, respectively. H2b: PAL2 intervention will be more cost-effective than usual care at 12 months and projected to be more cost-effective at 10 years. Health Equity Impact: Targeted deployment of MHUs and PAL2 can mitigate several key adverse SDoH. LEAP-HTN contributes to the RESTORE Network by testing a sustainable and scalable approach to advance health equity and prevent HTN in Black adults participants. If successful, the use of MHU can be easily implemented in similar urban Black communities across the U.S.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

330 Participants Needed

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:25 - 55

69 Participants Needed

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

600 Participants Needed

The purpose of this study is to examine how the environment and neighborhood characteristics affects the health of the area residents. The study will help determine how changing neighborhood characteristics, such as green space, affect heart health, risk factors for other diseases, sense of well- being or neighborhood cohesion.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 70

835 Participants Needed

This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal. Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 75

100 Participants Needed

Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched"). The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 4

11082 Participants Needed

The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are: * Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke? * Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes? * Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare? Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors. Participants will: * Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6. * Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare * Keep a log of their blood pressure
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:40 - 75

200 Participants Needed

The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 25

500 Participants Needed

Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are: * What is the feasibility of recruiting and retaining participants? * Are the study procedures appropriate to be translated to a larger future study? Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see if Participants will: * Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form. * Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours. * Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1

36 Participants Needed

This study is a substudy of the Strenghtening Community Roots (SCORE!) Cohort study. The investigators will look for people, enrolled in the SCORE! Cohort study, with abnormal results related to blood sugar and fat, as well as high blood pressure and heart disease risks. The investigaors will try to help the community improve sugar, fat and blood pressure through trained people who are not necessarily a medical doctor but have health-sciences-training backgrounds. These people are called Non-Physician Health Workers (NPHW), and they will be under the direction of a medical doctor and will be also in close communication with the participants and the medical doctor to improve their health. This will happen through a total of 12 months, having online and on-site visits, for follow-up.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

137 Participants Needed

This pilot study will assess the feasibility and generate preliminary efficacy data of a novel, synchronous, home-based exercise training program for rural older adults with cardiovascular disease (CVD) using Vivo, an online, live, small group fitness program developed for older adults. It uses individually tailored dual-tasked (i.e., cognitive-motor) exercises to improve strength, endurance, balance, and cognition and incorporates social engagement. Certified trainers deliver instruction and coaching through an interactive session (45 min, 2-3 times/week) delivered over 12 weeks. Vivo Heart adapts this unique program to meet the cardiac rehabilitation needs of older adults with CVD. The specific aims are to evaluate the feasibility, acceptability, and uptake of Vivo Heart (Aim 1) and obtain pre- and post-intervention measures of exercise capacity, strength, lower-extremity physical function, cognition, quality of life, stress, fatigability, physical activity, and aging biomarkers (Aim 2).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:60 - 80

27 Participants Needed

Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

186 Participants Needed

This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine. The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs. To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective. The researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

300 Participants Needed

Background: - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: - To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: - People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. * Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. * No treatment will be provided as part of this protocol.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

4000 Participants Needed

Why Other Patients Applied

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50
Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death. Managing these health issues can be done by changing diet and lifestyle. Specific ways of eating have been proven to improve risk for heart disease and stroke. However, because doctors often have limited time, nutrition education, and lack of tools for counseling patients on nutrition, they can often only provide minimal support to help patients make necessary lifestyle changes. Digital tools and mobile applications offer an opportunity to involve doctors and patients in delivering nutrition interventions. This approach has the potential to save time, provide education, and reduce healthcare costs. This study is being done to understand the effect of a digital heart health program added to standard of care, compared with standard of care alone on heart health. All eligible participants in this study will be randomized (determined by chance) to one of two possible interventions: 1) a digital heart health program + standard of care; 2) standard of care. Standard is care is defined as the best practice based on guidelines for the treatment of a condition. All participants will be followed for seven years and will be asked to complete online questionnaires and complete blood work at their nearest LifeLabs clinic, as well as wear a continuous glucose monitor and wrist actigraph (at 3 time points in the first year). In addition, participants randomized to the digital heart health program + standard of care will be expected to use the heart health app and join 16 online synchronous sessions over the first year. After seven years, the intervention phase of the study will end and the study will become a cohort study. All participants at the 7-year time point will be invited to use the heart health app. As part of the cohort study, participants will be asked to continue completing the same questionnaires online and completing bloodwork at their nearest LifeLabs every four years for the duration of their participation in the cohort study. The main questions this study aims to answer are: 1. Will a digital heart health program added to standard of care result in a clinically meaningful reduction in blood cholesterol and other risk factors after 1-year compared to standard of care alone? 2. Will a digital heart health program added to standard of care result in a reduction in major cardiovascular events after 7-years compared to standard of care alone? 3. Are the observed effects sustained beyond the 7-years of the intervention? We hypothesize that the digital heart health program added to standard of care will result in a clinically meaningful reduction in blood cholesterol and other risk factors for heart disease after 1-year and reduce major cardiovascular events after 7-years compared to standard of care alone.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:45+

1100 Participants Needed

This is a randomized, controlled, parallel study with 3 experimental arms aimed to assess the effect of a digital dietary intervention (web-based app, online behavior change curriculum) enhanced with 10 servings of vegetables and fruit (5 as dietary advice within the app, 5 within a dehydrated vegetable and fruit blend), with or without high Ultra Processed Food (UPF) soy-containing proteins compared to standard of care (usual care) on systolic blood pressure (SBP; primary outcome), and other key cardiometabolic endpoints over 12-weeks in adults living with hypertension and obesity, 50% with type 2 diabetes. The main questions this study aims to answer are: 1. Are nutrient-dense, high-UPF soy-protein foods similar (non-inferior) to low-UPF soy-protein foods in the context of a guidelines-based diet in their effect on blood pressure and other cardiometabolic risk factors? 2. Does an enhanced digital dietary intervention lead to meaningful reductions in blood pressure and other cardiometabolic risk factors compared to standard of care? Participants who are eligible and consent to be part of this study will be randomized to one of the following groups: 1) Active treatment (high-UPF soy-containing enhanced digital dietary intervention), 2) Reference treatment (low-UPF soy-containing enhanced digital dietary intervention), or 3) Control (standard of care). Participant Requirements: During the 12-week intervention, all participants will be required to attend in-person clinic visits at baseline (week 0), week 8 and 12. Baseline Visit (Week 0): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse). * Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit. * Bring fecal and urine samples from home. * Complete and review all questionnaires received via email one week prior. Telephone Check-in (Week 1): One week after beginning the study, the study staff will call participants to check in on how participants are following the protocol and answer any questions. Mid-Study Visit (Week 8): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Have their office blood pressure and anthropometric measurements taken. * Complete and review all questionnaires received via email one week prior * Review the 3-day food records completed using the Keenoa mobile app one week prior to clinic visit. Final Study Visit (Week 12): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse). * Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit. * Bring fecal and urine samples from home. * Complete and review all questionnaires received via email one week prior. Throughout the study, participants will be asked to continue their usual lifestyle and physical activity. Additional Requirements for Treatment Groups: Participants randomized to the active and reference treatment groups will also be required to: * Incorporate a study vegetable and fruit blend (provided) into their daily diet for the full 12 weeks * Consume soy products categorized as either high ultra processed soy foods at least 4 servings per day, including at least 2 servings of ultra processed soy milk and 2 servings of other soy-based products (e.g., soy yogurt, soy burgers, or soy ground round) or non-ultra processed soy foods at least 4 servings per day, including at least 2 servings of minimally processed soy milk, 1 serving of edamame or roasted soy nuts, and 1 serving of tofu or tempeh * Participate in the digital dietary intervention, which includes: a health app, 7-day Kickstart Package, weekly text message support, and a 7-session online interactive program designed based on behaviour change theory * Attend a virtual focus group at Week 4 and complete an online feedback questionnaire

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

300 Participants Needed

Background: Heart disease is a leading cause of death. People can reduce their heart disease risk by exercising more. Mobile health technology may make people more successful at increasing their exercise. This includes things like physical activity monitors and smartphone apps. Objective: To find out if mobile health technology can increase physical activity. Eligibility: African American women ages 21-75 who: * Are overweight or obese * Live in certain areas near Washington, DC * Have a smartphone that can use the study app Design: At visit 1, participants will * Answer survey questions. These may be about medical history, physical activity, and weight. They may also cover body image, health perception, and spirituality. * Have body size measured and get blood tests * Get a device to wear on the wrist. It will record physical activity and hours of sleep. * Learn how to download and use the study mobile app For 2 weeks, researchers will collect data about participants physical activity. Then participants will have a study visit with additional blood tests. All participants will get messages from the app that encourage exercise. Some participants will get data from the app about exercise near their home or work. Some participants may get face-to-face coaching. Participants may get wireless devices. These measure body weight, blood pressure, and blood glucose. Participants can measure these at home and upload the data to the app for the study. Participants will have visits after 3 and 6 months. They will repeat the visit 1 tests.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 75
Sex:Female

325 Participants Needed

The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preconception period or early pregnancy. The main aims include: 1. Determine the feasibility and acceptability of the LEAN into pregnancy study. 2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score. 3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia. A total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities: * Blood draws to test hemoglobin A1c and lipids * Surveys about diet, physical activity, sleep, and tobacco use * Gaples Nutritional Education Modules (if applicable)
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 35
Sex:Female

200 Participants Needed

The goal of this study is to learn how a supplement Quercetin can affect microvascular function. Participants will: * give two blood draws of 5 mL each * have a camera placed under the tongue to take pictures of blood vessels * have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 60

40 Participants Needed

Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering. Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

200 Participants Needed

MitoQ for COPD

Richmond, Virginia
Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.

Trial Details

Trial Status:Recruiting
Age:40+

24 Participants Needed

The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning platform designed to increase diversity in cardiovascular disease research among women and Black and Latino adults. CONNECT will deploy electronic health record (EHR)-informed and community-engaged recruitment approaches to identify and recruit adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on cardiovascular health and research participation via text message. Participants will also have the opportunity to be connected to ongoing cardiovascular research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The CONNECT platform will be used to evaluate recruitment methods. The investigators hypothesize the proportion of women and Black and Latin adults enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. Investigators also hypothesize that participating in CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

1000 Participants Needed

The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

600 Participants Needed

The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:12 - 22

25 Participants Needed

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Frequently Asked Questions

How much do Cardiovascular Health clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Cardiovascular Health clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Cardiovascular Health trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Cardiovascular Health is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Cardiovascular Health medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Cardiovascular Health clinical trials?

Most recently, we added TEAM-LEADS for Lupus and Dermatomyositis, Quercetin for Microvascular Health and BRILLIANT Platform for Brain Injury to the Power online platform.

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