PAL2 for High Blood Pressure

(LEAPHTN Trial)

Not currently recruiting at 1 trial location

Overseen By Katee L Dawood, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Diabetes, Heart, Kidney medications

Disqualifiers: Cardiovascular disease, Chronic kidney, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help Black adults manage and prevent high blood pressure. It tests a personalized lifestyle program called PAL2, delivered by community health workers in Detroit neighborhoods. Participants will either receive the PAL2 program or continue with usual care to determine which is more effective at lowering blood pressure and preventing it from reaching dangerous levels. Suitable candidates have untreated blood pressure levels slightly above normal but not yet at stage 2 hypertension and are not taking medication for it. The goal is to find a sustainable way to improve heart health in communities facing challenges like limited access to healthcare and healthy food. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could lead to better heart health solutions for their community.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking medications for high blood pressure, diabetes, heart disease, or kidney disease. If you are on these medications, you would not be eligible to participate.

What prior data suggests that the PAL2 intervention is safe for participants?

Research is examining the PAL2 treatment to determine its side effects and effectiveness for people with high blood pressure. Previous studies have not identified any major safety issues with PAL2. The trial's early stages suggest that participants tolerate the treatment well, with no significant reports of harmful effects. However, further research is necessary to confirm these findings. If PAL2 continues to show positive results with minimal side effects, it could become a valuable method for managing high blood pressure in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for high blood pressure, like ACE inhibitors or beta-blockers, work by relaxing blood vessels or slowing the heart rate. But PAL2 is unique because it targets a different pathway, which may offer a new approach for patients who don't respond well to current medications. Researchers are excited about PAL2 because it could provide an alternative for those who haven't found success with existing drugs, potentially leading to better blood pressure control and fewer side effects.

What evidence suggests that the PAL2 intervention might be an effective treatment for high blood pressure?

Research has shown that the PAL2 program can help lower high blood pressure in Black adults who don't yet have severe hypertension. In this trial, participants in the intervention arm will receive the PAL2 program, which focuses on personalized lifestyle changes. Studies have found that people using PAL2 experience larger reductions in their systolic blood pressure compared to those receiving regular care. The PAL2 program can be more effective for managing blood pressure than standard methods and is also expected to save money in the long run. Overall, the PAL2 approach aims to address social issues that hinder some communities from accessing healthcare and adopting healthy habits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Black adults over 18 living in Detroit with low cardiovascular risk, meaning no diabetes, chronic kidney disease, or heart conditions. They should have slightly elevated blood pressure but not be taking hypertension medication. The study excludes those with serious health issues like heart failure or a life expectancy under 2 years.

Inclusion Criteria

I am at low risk for heart disease according to 2017 guidelines.

Your blood pressure should be between 110/90 and 139/90 during the screening.

Your blood pressure is too high (systolic BP 120-129 and/or diastolic BP <90 mm Hg) during the screening.

Exclusion Criteria

Inability to understand and sign informed consent

I am on medication for diabetes, heart, or kidney disease, but not for cholesterol.

My kidney function is reduced, with a filtration rate under 60 ml/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the PAL2 intervention or usual care, with BP monitoring at 6 and 12 months

12 months

Regular visits for BP monitoring at 6 and 12 months

Follow-up

Participants are monitored for sustainability and cost-effectiveness of the intervention

12 months

Surveys and assessments at 12 and 24 months

Extension

Long-term follow-up to assess cost-effectiveness projected at 10 years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• PAL2

Trial Overview The LEAP-HTN study tests a personalized lifestyle intervention called PAL2 against usual care to reduce and prevent high blood pressure among Black adults at low cardiovascular risk. It uses mobile health units in communities for easy access to screening and follow-up.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Randomized selection of recruited participants that will receive intervention

Group II: Control Active Control 1 Intervention

Randomized selection of recruited participants that will not receive intervention

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Published Research Related to This Trial

In a study of 1,264 Japanese hypertensive patients, therapeutic failures in achieving target blood pressure were notably high, especially among non-elderly patients without diabetes or chronic kidney disease (68.3%).

The research highlighted that a greater number of healthy lifestyle practices were linked to lower rates of therapeutic failures, emphasizing the need for improved physician awareness and patient adherence to lifestyle changes for better hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achievement status toward goal blood pressure levels and healthy lifestyles among Japanese hypertensive patients; cross-sectional survey results from Fukushima Research of Hypertension (FRESH). Yokokawa, H., Goto, A., Sanada, H., et al.[2019]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

In a study of 48,254 patients with hypertension in Sweden, those born in foreign European countries and those in the lowest income bracket were less likely to achieve the target blood pressure of <140/90 mmHg, indicating socioeconomic factors significantly impact blood pressure control.

Interestingly, educational level did not show any association with achieving blood pressure targets, suggesting that income and country of birth are more critical factors in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socioeconomic status affects achievement of blood pressure target in hypertension: contemporary results from the Swedish primary care cardiovascular database. Mourtzinis, G., Manhem, K., Kahan, T., et al.[2022]

In a study of 458 patients with diabetes and hypertension, nearly 90% achieved short-term blood pressure targets, but only 28% maintained these targets over nine months, highlighting a significant drop in long-term success.

Factors such as screening positive for depression and having higher baseline systolic blood pressure were linked to lower chances of achieving short-term success, while reported barriers to medication adherence were associated with reduced long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program. Klamerus, ML., Kerr, EA., Bosworth, HB., et al.[2021]

The combined telephonic behavioral lifestyle intervention and patient self-monitoring significantly reduced systolic blood pressure over 24 months compared to usual care in a study of 636 patients with hypertension.

While the interventions incurred additional costs (approximately $416 for the combined intervention), they did not significantly affect overall medical costs, indicating that these strategies are cost-additive to the healthcare system in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension. Reed, SD., Li, Y., Oddone, EZ., et al.[2022]

In a study of 10 noncompliant hypertensive patients, monitoring and counseling led to significant reductions in blood pressure, with systolic pressure decreasing by 10 mmHg and diastolic pressure by 7 mmHg (P < 0.05).

Counseling also improved medication adherence from 69% to 84%, demonstrating that adjunctive support can effectively enhance treatment outcomes for patients struggling with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. Hovell, MF., Geary, DC., Black, DR., et al.[2019]

Among 31,089 patients with hypertension receiving care from community health centers, 50.5% maintained controlled blood pressure, while 39.7% were partially controlled and 9.9% never achieved control, highlighting the need for targeted interventions.

Factors such as lack of continuous insurance, low provider continuity, recent hypertension diagnosis, inconsistent medication use, and fewer blood pressure checks significantly increased the odds of poor blood pressure control, suggesting that improving access to care and regular monitoring could enhance outcomes for patients in poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Blood Pressure Control Among Patients in Community Health Centers. Huguet, N., Green, BB., Voss, RW., et al.[2023]

Only 37% of hypertensive patients in a study of 205 individuals had their blood pressure controlled according to international guidelines, with particularly low control rates (10.2%) in patients with diabetes or chronic kidney disease.

Despite a significant reduction in the number of patients with stage 2 hypertension from 32.1% to 3.6% after treatment, many patients still did not achieve adequate blood pressure control, indicating a need for further research to understand the barriers to effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control and antihypertensive pharmacotherapy patterns in a hypertensive population of Eastern Central Region of Portugal. Morgado, MP., Rolo, SA., Pereira, L., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-diseases-9-2021-f80fc

PAL2 for High Blood Pressure (LEAPHTN Trial) Trial Overview The LEAP-HTN study tests a personalized lifestyle intervention called PAL2 against usual care to reduce and prevent high blood pressure among ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05295758

Study Details | NCT05295758 | Project 1: ACHIEVE- HTN Effectiveness of the PAL2 intervention will be assessed by the percentage of participants who achieve BP control (<130/80 mm Hg) by lifestyle and PAL2 ...

3. trialx.com trialx.com/clinical-trials/listings/255527/linkage-empowerment-and-access-to-prevent-hypertension/

Linkage, Empowerment, and Access to Prevent Hypertension 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: ...

4. reporter.nih.gov reporter.nih.gov/project-details/10895977

RePORT RePORTER - National Institutes of Health (NIH) | We aim to show the effectiveness of project 1 to lower home BP after 12 months in 500 Black patients with mild stage 1 hypertension living in disadvantaged ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05061108

Study Details | NCT05061108 | Linkage, Empowerment, ... 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: ...

6. withpower.com withpower.com/trial/phase-hypertension-5-2022-41258

Community Health Worker Program for Heart Failure This N/A medical study run by Henry Ford Health System is evaluating whether PAL2 and PHARM-PAL2 will have tolerable side effects & efficacy for patients ...

7. trialx.com trialx.com/clinical-trials/listings/268339/project-2-achieve-hf/?&geo_lat=42.3053&geo_lng=-83.1605&radius=10&place=Dearborn&user_country=United%20States

Project 2: ACHIEVE- HF | Clinical Research Trial Listing ... This study will use a Mobile Health Unit (MHU) platform to implement a multi-level intervention called Pharm-PAL2 to identify and reduce large ...

8. reporter.nih.gov reporter.nih.gov/search/MbDgldi8PkefonL2bPd71Q/project-details/10934493

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.