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Pacemaker Therapy

Pacemaker Therapy for Heart Failure (FIRE-HFpEF Trial)

Q: Are there any remaining slots available for enrollment in this medical trial?

<p>According to clinicaltrials.gov, this trial is not in need of patients at the moment; its initial posting was on September 1st 2023 and it's most recent edition was published on 9/26/2023. However, there are 849 other trials that require volunteers immediately.</p>

N/A

Waitlist Available

Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m^2

New York Heart Association (NYHA) Functional Class I-III

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, projected for three years until last subject last 12-month visit.

Awards & highlights

FIRE-HFpEF Trial Summary

This trial tests if treatments like pacing can improve exercise capacity & health status for people with Heart Failure & Preserved Ejection Fraction.

Who is the study for?

This trial is for people with heart failure who still have normal or near-normal heart pumping function (LVEF ≥ 55%), specifically those in NYHA Functional Class I-III without severe symptoms. Participants should show signs of a thickened heart muscle and be stable on standard heart failure meds, except diuretics, for at least a month. They can't join if they need a pacemaker for other reasons, have severe chest pain during exercise, permanent A-fib, recent valve surgery, serious lung disease like COPD, very low kidney function (eGFR < 25), uncontrolled high blood pressure despite treatment, or certain types of cardiomyopathy.Check my eligibility

What is being tested?

The FIRE-HFpEF study is testing whether special pacing therapies from pacemakers can improve the ability to exercise and overall health in patients with Heart Failure with Preserved Ejection Fraction (HFpEF). It's comparing two different pacemaker settings to see which might work better. Up to 105 participants will be randomly assigned to one of these treatments at multiple centers.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with pacemaker implantation may include infection at the site of implantation, bleeding or bruising around the area where it was placed under the skin; discomfort or swelling; potential lead displacement; and rarely more serious complications such as damage to nearby structures including nerves or blood vessels.

FIRE-HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's size is within the normal range for my body size.

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My heart condition allows me to perform daily activities with minimal to moderate difficulty.

FIRE-HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, projected for three years until last subject last 12-month visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, projected for three years until last subject last 12-month visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, projected for three years until last subject last 12-month visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in left ventricular volumes as assessed by cardiac MRI compared from baseline to 7,10, and 12-month follow-up visits.

Characterize the effect of pacing therapies on functional status, defined as change in 6-minute walk test from baseline to 7, 10, and 12 months.

Characterize the effect of pacing therapies on functional status, defined as change in device-measured accelerometer data from baseline to 3, 7, 10, and 12 months.

+1 more

Secondary outcome measures

Characterize durability of changes in cardiac structure and/or health & functional status following the modification or cessation of pacing therapies at 7, 10, and 12 months.

Characterize the impact of AVNS therapy on changes in serum biomarkers: Tumor Necrosis Factor (TNF-α), Interleukin 6 (IL-6) Interleukin 1 beta (IL-1β) from pre-implant to 0 hours, 4 hours, 24 hours and 6 weeks post-implant.

FIRE-HFpEF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pacemaker with multiple pacing therapies enabledExperimental Treatment2 Interventions

Device will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).

Group II: Pacemaker with modified pacing therapy onActive Control2 Interventions

Device will be programmed for personalized lower rate pacing (PLR).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor

198 Previous Clinical Trials

128,825 Total Patients Enrolled

78 Trials studying Heart Failure

65,728 Patients Enrolled for Heart Failure

Tom MullenStudy DirectorMedtronic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots available for enrollment in this medical trial?

"According to clinicaltrials.gov, this trial is not in need of patients at the moment; its initial posting was on September 1st 2023 and it's most recent edition was published on 9/26/2023. However, there are 849 other trials that require volunteers immediately."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

2023. "Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839730.