Heart Failure Clinical Trial

Project 2: ACHIEVE- HF

Summary

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 2 of the ACHIEVE GREATER Center.

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Full Description

Heart failure (HF) is one of the most common, costly, and deadly diseases affecting humans. Hypertension is the largest single risk factor for HF, accounting for over half of all new cases. Moreover, Black adults with hypertension have a much greater risk, perhaps 20-fold, of developing HF compared with White adults. The data the investigators collected in Detroit, MI, where the population is predominantly Black, features a mortality rate from heart disease that is nearly twice the national average. Among patients with hypertension and no history of HF, more than 50% already have abnormalities of cardiac function seen on echocardiogram. Notably, high rates of hypertension in the Black community comingle with diabetes and kidney dysfunction, further amplifying HF risk.

Accordingly, early interventions to prevent HF, in particular blood pressure (BP) control, are critical. However, implementation of effective treatments remains suboptimal among Black communities, especially in low-income urban settings. While many factors are involved, mounting evidence shows that adverse social determinants of heath (SDoH) such as poor access to healthcare, food insecurity, and lack of safe places for physical activity are critical barriers to the implementation of recommended therapies. To achieve health equity, improved strategies must be developed to overcome these negative SDoH. To better engage the at-risk community, the team of investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct health services to communities in highest need, who may not otherwise engage with traditional health care settings.

Project 2 (ACHIEVE HF) of ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region) will address multiple domains and levels of impact to reduce the large gaps in care of stage A HF patients in the Black community and prevent progression towards later stages of disease. The project proposes an innovative approach to identify and control hypertension (HTN) at it's earliest stages in undiagnosed Black adults. This study will use a Mobile Health Unit (MHU) platform to implement a multi-level intervention called Pharm-PAL2 to identify and reduce large gaps in care of stage A HF in untreated Black adults. The Pharm-PAL2 intervention will be delivered to the intervention arm participants in two phases: Intervention phase (first 12 months) and Durability Phase (Year 2, an additional 12 months).

The Pharm-PAL2 intervention will link Black adults with 1 of the inclusion factors below to collaborative care delivered by non-physicians, community health workers (CHWs) and Pharmacists via MHUs.

screening systolic blood pressure >= 140 and/or diastolic blood pressure >= 90 mmHg or
screening blood pressure 130-139 mmHg plus >1 additional heart failure risk factor (1. diabetes (HbA1c >=6.5% or 2. CKD stage 3 (i.e. eGFR 30-60 mL/min/m^2)) or
treated (1-2 antihypertensive medications) stage 1 hypertension (systolic BP 130-139 and/or diastolic BP 80-89) with or without additional heart failure risk factors

View Eligibility Criteria

Eligibility Criteria

Inclusion:

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

Self-identified Black/African American
Detroit-area resident (defined as those who attended a Detroit-area community event)
≥18 years of age
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

Exclusion Criteria:

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

Previous diagnosis of HF
Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
Current use >2 anti-hypertensive medications (resistant hypertension)
Chronic use of insulin or >1 anti-diabetic medication
Self-reported pregnancy (or planning to become pregnant in the next year)
Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP > 110)
NTproBNP ≥ 1000 ng/L from SOC screening labs

Study is for people with:

Heart Failure

Estimated Enrollment:

364

Study ID:

NCT05330221

Recruitment Status:

Recruiting

Sponsor:

Henry Ford Health System

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There is 1 Location for this study

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Wayne State University
Detroit Michigan, 48201, United States More Info
Paul Kurian
Contact
313-448-9817
[email protected]

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Study is for people with:

Heart Failure

Estimated Enrollment:

364

Study ID:

NCT05330221

Recruitment Status:

Recruiting

Sponsor:


Henry Ford Health System

How clear is this clinincal trial information?

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