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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title EXercise and Activin Inhibition to Modulate InflammatioN Effects on Heart Failure and Cognition (EXAMINE-HFC)
ClinicalTrials.gov ID: NCT07202000
What this study is testing
What is Activin ligand-trap biological therapy?
Activin ligand-trap biological therapy is an investigational medicine, being studied as a potential treatment for heart failure with preserved ejection fraction.
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
- The goal of this clinical trial is to learn if therapy with activin ligand-trap biological therapy (an investigational drug) combined with exercise training can improve exercise capacity and cognitive function in heart failure with preserved ejection fraction (HFpEF). The main questions it aims to answer are: Does activin-ligand trap biological therapy improve exercise capacity as measured by change in peak oxygen uptake (peak VO2) from baseline to week 12?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Adult ≥ 40 years of age;
- Body mass index ≥ 27 kg/m2;
- Left ventricular ejection fraction (LVEF) ≥ 0.50 with NYHA II-III;
- Established diagnosis of HFpEF based on medical history supported by at least one of the following 5 criteria (i through v, below) i. Documented...
- Achievement of a respiratory exchange ratio (RER) at baseline CPET of ≥ 1.05 to ensure maximum volitional effort was provided;
You likely can't join if
- Conditions anticipated to independently impact exercise capacity or clinical stability during the trial period
- Current or recent (within 30 days) acute decompensated HF requiring intravenous diuretics or hospitalization;
- Initiation of treatment with GLP-1 receptor agonist or SGLT2 inhibitor within 60 days of screening;
- Planned cardiac surgery or catheter intervention during the period of trial participation;
- Entry within 30 days of screening or plans to enter a weight loss program and/or cardiac rehabilitation or initiate any new exercise program during...
- Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital), LVEF \< 40% within the last 3 years, or...
See the full eligibility criteria
- Adult ≥ 40 years of age;
- Body mass index ≥ 27 kg/m2;
- Left ventricular ejection fraction (LVEF) ≥ 0.50 with NYHA II-III;
- Established diagnosis of HFpEF based on medical history supported by at least one of the following 5 criteria (i through v, below) i. Documented hospitalization with HFpEF as a primary cause or other urgent outpatient...
- Achievement of a respiratory exchange ratio (RER) at baseline CPET of ≥ 1.05 to ensure maximum volitional effort was provided;
- Ambulatory (not wheelchair/scooter-dependent) and able to perform CPET/6MWT/Chair stand evaluations;
- Stable dose of medications (defined as no new medication or change in existing dose of medication ≥ 50%) for at least 30 days prior to screening.
- Conditions anticipated to independently impact exercise capacity or clinical stability during the trial period
- Current or recent (within 30 days) acute decompensated HF requiring intravenous diuretics or hospitalization;
- Initiation of treatment with GLP-1 receptor agonist or SGLT2 inhibitor within 60 days of screening;
- Planned cardiac surgery or catheter intervention during the period of trial participation;
- Entry within 30 days of screening or plans to enter a weight loss program and/or cardiac rehabilitation or initiate any new exercise program during the study.
- Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital), LVEF \< 40% within the last 3 years, or active myocarditis;
- Lactating, pregnant, or planning to become pregnant;
- Non-cardiac organ system dysfunction or sufficient severity to predominate as the source of exercise intolerance in addition to the following specific criteria: pulmonary disease with chronic home daytime supplemental...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.