Linkage, Empowerment, and Access to Prevent Hypertension

Launched by WAYNE STATE UNIVERSITY · Sep 17, 2021

Keywords

ClinConnect Summary

The Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study is investigating a new way to help Black adults lower their blood pressure and prevent serious health issues like heart disease. The trial focuses on people aged 18 and older living in the Detroit area who have slightly elevated blood pressure but are not currently taking medication for it. To be eligible, participants should identify as Black, have a systolic blood pressure between 110-139 mm Hg, and not have any major health conditions like diabetes or heart disease.

Participants in the study will receive support from community health workers who will guide them through personalized lifestyle changes to improve their health. The aim is to see if this tailored approach is more effective than standard care in reducing blood pressure over 6 and 12 months. Throughout the study, participants can expect regular check-ins and follow-up visits to monitor their progress. This research is particularly important because it seeks to address health disparities and improve access to care in communities that have been historically underserved. If successful, the strategies from this trial could be applied in other similar communities across the country.

Gender

ALL

Eligibility 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