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19 Single Ventricle Heart Trials Near You

Power is an online platform that helps thousands of Single Ventricle Heart 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

Home-Delivered Meals + Additional Services for Health Improvement

Columbus, Ohio
This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:60+

56 Participants Needed

Tissue Engineered Vascular Grafts for Heart Disease

Columbus, Ohio
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

24 Participants Needed

Udenafil for Single Ventricle Heart Disease

Columbus, Ohio
This trial tests udenafil, a medication that improves blood flow, on adolescents who have had heart surgery (Fontan procedure). It works by relaxing blood vessels to help them exercise better.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 18

436 Participants Needed

Stem Cell Therapy for Hypoplastic Left Heart Syndrome

Cincinnati, Ohio
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:< 12

95 Participants Needed

Wellness & Exercise Program for Single Ventricle Heart Disease

Ann Arbor, Michigan
This trial is testing if teaching kids about health in groups and giving them custom exercise plans can help children with a special heart condition become healthier and more active.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 18

30 Participants Needed

Near Infrared Spectroscopy for Single Ventricle Heart

Oak Lawn, Illinois
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:< 6

20 Participants Needed

Cardiac Rehabilitation for Congenital Heart Failure

Nashville, Tennessee
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

Ventripoint Echocardiography for Single Ventricle Heart

Durham, North Carolina
This trial will test a new 3D ultrasound method to better measure heart size and function in children and young adults with single-ventricle hearts. Current methods struggle with accuracy due to the unique shapes of these hearts. The new technique uses coordinates to create detailed 3D images, aiming for more precise measurements.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

100 Participants Needed

Digoxin for Single Ventricle Heart

Durham, North Carolina
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records. Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:30 - 6

20 Participants Needed

Spironolactone for Single Ventricle Heart Condition

Philadelphia, Pennsylvania
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics. This project investigates the response to acute imposition of Fontan hemodynamics by examining the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion along with a pilot trial of the antifibrotic agent, spironolactone, to prevent these consequences and to determine if MRI can discern these differences. The combination of serum biomarkers and MRI form a powerful non-invasive tool in putting together this complicated web of dysfunction.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:1 - 6

145 Participants Needed

Digital Exercise for Congenital Heart Disease

Philadelphia, Pennsylvania
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are: * Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention? Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective. All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months. In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components: * aerobic exercise * resistance exercise * engagement strategies
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 17

200 Participants Needed

Lumason Administration Methods for Heart Disease

Atlanta, Georgia
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Not Yet Recruiting

106 Participants Needed

iPSC-CL for Congenital Heart Disease

Rochester, Minnesota
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 40

50 Participants Needed

Dapagliflozin for Fontan Circulation

Rochester, Minnesota
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.
Prior Safety Data

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

27 Participants Needed

Ultrasound Contrast Agents for Heart Imaging

Kansas City, Missouri
This trial tests MVT-100, a new ultrasound contrast agent, in healthy volunteers. It aims to see if MVT-100 is safe and effective for improving heart images by using tiny bubbles that reflect ultrasound waves. The study compares MVT-100 to an existing product.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:19+

16 Participants Needed

Implantable Loop Recorder for Single Ventricle Heart Defects

Boston, Massachusetts
The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period. An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:< 30

10 Participants Needed

Exercise for Single Ventricle Heart

Irving, Texas
This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10 - 40

50 Participants Needed

Remote Monitoring for Pediatric Heart Disease

Edmonton, Alberta
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:< 17

20 Participants Needed

Supervised Exercise for Single Ventricle Heart Condition

Palo Alto, California
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 19

150 Participants Needed

Why Other Patients Applied

"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've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"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

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"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

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Why We Started Power

We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.

Bask
Bask GillCEO at Power
Learn More About Trials
How Do Clinical Trials Work?Are Clinical Trials Safe?What Can I Expect During a Clinical Trial?

Frequently Asked Questions

How much do Single Ventricle Heart 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 Single Ventricle Heart 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 Single Ventricle Heart 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 Single Ventricle Heart 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 Single Ventricle Heart 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 Single Ventricle Heart clinical trials?

Most recently, we added Digital Exercise for Congenital Heart Disease, Dapagliflozin for Fontan Circulation and Digoxin for Single Ventricle Heart to the Power online platform.

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