Status:
RECRUITING
Project 2: ACHIEVE- HF
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Wayne State University
Conditions:
Heart Failure
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 re...
Detailed 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. Accordingl...
Eligibility Criteria
Inclusion
- 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:
- 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:
- Previous diagnosis of HF
- Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
- 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 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.
- eGFR \<45 ml/min/sq-m on SOC screening labs
Exclusion
Key Trial Info
Start Date :
January 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT05330221
Start Date
January 18 2023
End Date
June 30 2027
Last Update
September 19 2025
Active Locations (1)
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1
Wayne State University
Detroit, Michigan, United States, 48201