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Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Study acronym: FIRE-HFpEF
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jul 2026 → Oct 2027
See other at-risk trials from Medtronic Cardiac Rhythm and Heart Failure

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2026 to Oct 2027
    • Enrollment closed, study ongoing
    • Study completion pushed from Jul 2027 to Oct 2027
    • Site details revised at 8 of 8 sites
    v17
  2. Study sites: 9 to 8v16
  3. Re-verified, no change to tracked fieldsv15
  4. Primary completion date: Jan 2026 to Jul 2026
    • Study completion date: Jan 2026 to Jul 2027
    • Site details revised at 2 of 9 sites
    v14
  5. Study sites: 8 to 9v13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 9 to 8
    v12
  2. Trial status: Suspended to Active, Not Recruiting
    • Start date: Sep 26, 2023 to Sep 11, 2024
    • Study sites: 6 to 9
    v11
  3. Primary endpoints: 4 to 3v10 Show 4 more changesShow less
    • Study sites: 4 to 6
    • Interventions: Pacemaker PLR + TRT ON (Device), Pacemaker PLR ON (Device) to Pacemaker PLR + TRT ON (Device), Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest…
    • Secondary endpoints shortened, about 61 words
    • Study description shortened, about 10 words
  4. Trial status: Recruiting to Suspended Sponsor's reason: Revision of the protocol
    • Study sites: 3 to 4
    v9
  5. Study sites: 2 to 3v8
  6. Study sites: 1 to 2v7
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Sep 26, 2023
    • Site details revised
    v6
  8. Study sites: 0 to 1v5
  9. Start date: Aug 2023 to Sep 2023v4
  10. Start date: Jul 2023 to Aug 2023v3
  11. Start date: May 2023 to Jul 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05839730
Lead Sponsor Medtronic Cardiac Rhythm and Heart Failure
Conditions
(from sponsor)		 Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov