Trials / Recruiting
RecruitingNCT05839730
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. After 6 weeks, subjects will have a follow up visit with a blood draw and a cardiac MRI. At this visit, subjects will be randomized 2:1 for pacing therapy or as a control (programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest). After 3, 6 and 9 months after randomization, subjects will return for a follow up visit. At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment: pacing therapy will be terminated in the original therapy group and enabled in the control group. After an additional 3-months of follow-up, subjects will return for their final visit, therapies will be disabled in all subjects and subjects will be exited. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacemaker PLR + TRT ON | RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON |
| DEVICE | Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest. | RAMware modified implantable pulse generator (IPG) |
Timeline
- Start date
- 2024-09-11
- Primary completion
- 2026-07-01
- Completion
- 2027-07-01
- First posted
- 2023-05-03
- Last updated
- 2026-01-27
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05839730. Inclusion in this directory is not an endorsement.