Preventing heart failure in at-risk Black adults in Detroit and Cleveland

ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region

This study is testing a program delivered by Community Health Workers to help Black adults in Detroit and Cleveland prevent heart failure by managing high blood pressure and improving overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 364 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT05330221 on ClinicalTrials.gov

What this trial studies

This project aims to reduce cardiometabolic health disparities and lifespan inequality related to heart failure and hypertension among Black adults in Detroit, Michigan, and Cleveland, Ohio. The intervention involves Community Health Workers (CHWs) delivering an evidence-based program called PAL2, which focuses on early prevention and management of hypertension to mitigate the risk of heart failure. The study also incorporates structured training for CHWs to enhance their effectiveness in engaging the community and addressing social determinants of health that contribute to these disparities.

Who should consider this trial

Good fit: Ideal candidates for this study are Black adults aged 18 and older residing in the Detroit area with hypertension or related risk factors for heart failure.

Not a fit: Patients with a previous diagnosis of heart failure or uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this project could significantly reduce the incidence of heart failure and improve overall health outcomes for Black adults in urban settings.

How similar studies have performed: Other studies have shown success in using community health workers to address health disparities, making this approach promising yet still innovative in its specific application to heart failure prevention.

Eligibility criteria

Inclusion:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Detroit-area resident (defined as those who attended a Detroit-area community event)
2. ≥18 years of age
3. At least one of the following:

A) Screening systolic BP ≥ 140 and/or diastolic BP ≥ 90 mm Hg OR

B) Screening BP 130-139 mm Hg plus ≥1 additional HF risk factors:

i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2) OR C) Treated (1-2 antihypertensive medications) stage 1 HTN (systolic BP 130-139 and/or diastolic BP 80-89) with or without \>1 additional HF risk factors OR

D) Treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors:

i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Previous diagnosis of HF
2. Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
3. Chronic use of insulin or \>1 anti-diabetic medication
4. Self-reported pregnancy (or planning to become pregnant in the next year)
5. Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP ≥110 mmHg)
6. Point of care (POC) BNP measurement ≥400 ng/L. If POC BNP was not obtained, then NTproBNP ≥ 1000 ng/L from screening labs will be excluded.
7. eGFR \<45 ml/min/sq-m on SOC screening labs

Where this trial is running

Detroit, Michigan

• Wayne State University — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Whitney Cabral, MS

Conditions Heart Failure; Hypertension; Prevention