Paced Heart Rate Acceleration for Cardiac Conditioning

Summary

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.

Conditions

• Heart Failure, Systolic

Interventions

DEVICE

Exercise-similar cardiac pacing

Cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.

DEVICE

Sham cardiac pacing

Simulated (rates selected using programmer but not initiated) cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Denice Hodgson-Zingman, MD

  lead OTHER

Principal Investigators

• Denice Hodgson-Zingman, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-26

Primary Completion

2028-06-30

Completion

2028-11-30

Countries

• United States

Study Locations