RecruitingNot ApplicableNCT05839730

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction


Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Enrollment

105 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether short-term supervised fasting (calorie restriction) can help improve heart function in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but the muscle is too stiff to fill properly, often linked to obesity and metabolic problems. **You may be eligible if...** - You have been diagnosed with HFpEF (heart pumping fraction of 55% or more) - Your heart failure symptoms are mild to moderate (NYHA Class I to III) - You have been stable on heart failure medications for at least 1 month - You are medically appropriate for a supervised dietary intervention **You may NOT be eligible if...** - You have a different type of heart failure (pumping fraction below 55%) - You have uncontrolled diabetes that would make supervised fasting unsafe - You have been hospitalized for heart failure very recently - You have serious kidney, liver, or other organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPacemaker PLR + TRT ON

RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON

DEVICEPacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

RAMware modified implantable pulse generator (IPG)


Locations(8)

NCH Heart Institute

Naples, Florida, United States

Prairie Education and Research Cooperative-St. Elizabeth's

O'Fallon, Illinois, United States

Prairie Education and Research Cooperative-St. John's

Springfield, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Duke University

Durham, North Carolina, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Houston Methodist Research Institute

Houston, Texas, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

View Full Details on ClinicalTrials.gov

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NCT05839730


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