NCT05330221Active, not recruiting
Project 2: ACHIEVE- HF
ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves four 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, Projects 2 and 4) and coronary heart disease (CHD, Project 3). The first three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. Projects 1-3 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- First submitted
- 21 Mar 2022
- Start date
- 18 Jan 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Henry Ford Health System
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT05330221
What you commit to
- Study type: Interventional
- Planned participants: 364
- From 18 Jan 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of HF
- Chronic use of insulin or \>1 anti-diabetic medication
Lab values
- Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
- eGFR \<45 ml/min/sq-m on SOC screening labs
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 mmHg)
- 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.
Criteria the registry did not label
- Inclusion:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Detroit-area resident (defined as those who attended a Detroit-area community event)
- ≥18 years of age
- At least one of the following:
- Screening systolic BP ≥ 140 and/or diastolic BP ≥ 90 mm Hg OR
- Screening BP 130-139 mm Hg plus ≥1 additional HF risk factors:
- 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
- Treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors:
- Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.