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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT05839730
What this study is testing
- What it's testing
- FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States.
- 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
You may be able to join if
- Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).
- New York Heart Association (NYHA) Functional Class I-III
- Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the...
- V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m\^2.
- Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:
You likely can't join if
- Unable or unwilling to undergo contrast MRI.
- Class I indication for permanent pacing, except for symptomatic chronotropic incompetence
- Current permanent or persistent Atrial fibrillation (A-fib)
- Structural heart disease requiring intervention
- Aortic valve replacement procedure less than 12 months prior to enrollment
- Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
See the full eligibility criteria
- Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).
- New York Heart Association (NYHA) Functional Class I-III
- Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with...
- V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m\^2.
- Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:
- Left ventricular (LV) posterior or lateral wall thickness \> 11mm
- Relative wall thickness (RWT) \> 0.42
- Male and LV mass indexed to BSA ≥115 g/m2
- Male and LV mass indexed to height ≥ 49.2 g/m2.7
- Female and LV mass indexed to BSA ≥ 95 g/m2
- Female and LV mass indexed to height ≥ 46.7 g/m2.7
- Unable or unwilling to undergo contrast MRI.
- Class I indication for permanent pacing, except for symptomatic chronotropic incompetence
- Current permanent or persistent Atrial fibrillation (A-fib)
- Structural heart disease requiring intervention
- Aortic valve replacement procedure less than 12 months prior to enrollment
- Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
- Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area \< 1cm\^2
- Exertional angina
- Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary...
- Estimated glomerular filtration rate (eGFR) \< 25 ml/min/1.73m\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula
- Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Florida, United States
- O'Fallon, Illinois, United States
- Springfield, Illinois, United States
- Kansas City, Kansas, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Burlington, Vermont, United States
Compensation & support
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Florida, United States; O'Fallon, Illinois, United States; Springfield, Illinois, United States; Kansas City, Kansas, United States; Durham, North Carolina, United States; Oklahoma City, Oklahoma, United States and 2 more location(s). 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.