Paced Heart Rate Acceleration for Cardiac Conditioning

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Denice Hodgson-Zingman, MD
Study ID
NCT06332391
Status
Recruiting
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Conditions

  • Heart Failure, Systolic

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise-similar cardiac pacing — DEVICE
    Cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.
  • Sham cardiac pacing — DEVICE
    Simulated (rates selected using programmer but not initiated) cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.

Study Details

A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed.

Key Dates

Start date
Jun 26, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise-similar cardiac pacing
    Atrial pacing to replicate exercise heart rate envelope once daily, 3 days per week, over 6 weeks while symptoms and vital signs are monitored and outcome measures assessed.
  • Sham Comparator: Sham cardiac pacing
    Sham pacing to replicate exercise heart rate envelope once daily, 3 days per week, over 6 weeks while symptoms and vital signs are monitored and outcome measures assessed.

Primary Outcome Measure

Change in left ventricular ejection fraction by echocardiogram [ Time Frame: at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Denice Hodgson-Zingman, MD
319-356-1616
Melissa Yoder, RN
[email protected]
319-384-1628
Denice Hodgson-Zingman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Iowa Hospitals and Clinics· Iowa City, IA

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