BridgeMD
New treatment option for Heart Failure
Official title Project 2: ACHIEVE- HF
ClinicalTrials.gov ID: NCT05330221
What this study is testing
What is PHARM-PAL2?
PHARM-PAL2 is an investigational medicine, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.