Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Part of paid clinical trials in Naples, Florida.

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT05839730
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pacemaker PLR + TRT ON — DEVICE
    RAMware 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. — DEVICE
    RAMware modified implantable pulse generator (IPG)

Study Details

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.

Key Dates

Start date
Sep 11, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pacemaker with multiple pacing therapies enabled
    Device will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).
  • Active Comparator: Pacemaker with no pacing therapies enabled
    Device will be programmed to a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

Primary Outcome Measure

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. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
NCH Heart InstituteNaplesFlorida34102
Dinesh Sharma, MD
Prairie Education and Research Cooperative-St. Elizabeth'sO'FallonIllinois62269
Ziad Issa, MD
Prairie Education and Research Cooperative-St. John'sSpringfieldIllinois62769
Ziad Issa, MD
University of Kansas Medical CenterKansas CityKansas66160
Seth Sheldon, MD
Duke UniversityDurhamNorth Carolina27708
Daniel Friedman, MD
Oklahoma Heart HospitalOklahoma CityOklahoma73120
Charles Te, MD
Houston Methodist Research InstituteHoustonTexas77030
Miguel Valderrabano, MD
The University of Vermont Medical CenterBurlingtonVermont05401
Nicole Habel, MD

Find similar trials in Naples, FL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
NCH Heart Institute· Naples, FLPrairie Education and Research Cooperative-St. Elizabeth's· O'Fallon, ILPrairie Education and Research Cooperative-St. John's· Springfield, ILUniversity of Kansas Medical Center· Kansas City, KSDuke University· Durham, NCOklahoma Heart Hospital· Oklahoma City, OK

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