Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines and include consideration of Sodium/glucose cotransporter-2 inhibitors (SGLT2i) therapy.
V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m².
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Pacemaker PLR + TRT ON
DeviceRAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON
Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
DeviceRAMware modified implantable pulse generator (IPG)
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: Pacemaker with multiple pacing therapies enabledExperimental treatment 1 intervention
Group B: Pacemaker with no pacing therapies enabledActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits.
Time frame
Through study completion, projected for three years until last subject last 12-month visit.2
Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life. Each of the 21 questions are scored on a 6-point Likert Scale (0 to 5), the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Time frame
Through study completion, projected for three years until last subject last 12-month visit.3
Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.
Time frame
Through study completion, projected for three years until last subject last 12-month visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov