Program to prevent hypertension in Black adults
Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN)
This study is testing a program that helps Black adults in Detroit with slightly high blood pressure make healthy lifestyle changes to prevent hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05061108 on ClinicalTrials.gov |
What this trial studies
This program focuses on preventing hypertension among Black adults in the Detroit area by promoting lifestyle modifications. It targets individuals with mild elevations in blood pressure who are at low cardiovascular risk and not currently on hypertension medications. The intervention aims to address social determinants of health that hinder effective implementation of lifestyle changes, such as access to healthcare and healthy food. Participants will receive support through the PAL2 intervention to empower them in managing their blood pressure.
Who should consider this trial
Good fit: Ideal candidates are Black adults aged 18 and older living in the Detroit area with mild hypertension and low cardiovascular risk.
Not a fit: Patients with existing cardiovascular diseases, diabetes, or chronic kidney disease will not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of hypertension and related cardiovascular diseases in Black communities.
How similar studies have performed: Other studies have shown success in implementing lifestyle modifications for hypertension prevention in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Self-identification as Black, age ≥18 years, living in the Detroit-area 2. Systolic BP 110-139 and diastolic BP \<90 mm Hg upon screening 3. Not currently taking medications for HTN 4. Low cardiovascular risk as defined by 2017 AHA/ACC HTN guidelines (no diabetes, no chronic kidney disease, no established ASCVD 5. 10-year ASCVD risk \<10% if systolic BP is in stage-1 hypertension range (130-139 mm Hg and \< 65 years old Exclusion Criteria: 1. Any clinical cardiovascular disease (e.g., coronary artery disease, heart failure, stroke, arrhythmia) 2. Chronic kidney disease or glomerular filtration rate \<60 ml/min on screening laboratory testing 3. Diabetes or HbA1c ≥ 6.5% on screening laboratory testing 4. LDL-C ≥ 190 mg/dL on screening laboratory testing (on or off medications) 5. ASCVD risk score calculated ≥ 10% for 10 years by clinical calculator on screening (if stage-1 systolic HTN only)2 6. Inability or not willing to follow-up with PAL2 research or usual care limb and at 6 \& 12-months at the MHU 7. Taking any medications for diabetes, heart disease or kidney disease. Cholesterol medication is not an exclusion 8. Inability to understand and sign informed consent 10. Chronic condition (e.g., cancer) with a potential life expectancy \< 2 years
Where this trial is running
Detroit, Michigan
- Wayne Health — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Phillip Levy, MD
- Email: plevy@med.wayne.edu
- Phone: 313-577-1214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.