A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female sex

• Age 18 years or greater

• Available transportation for study visits

• Left ventricular ejection fraction \< or = 40% despite at least 3 months guideline-directed medial therapy

• NYHA class II-III heart failure symptoms

• Atrial-lead inclusive implantable cardioverter defibrillator or biventricular defibrillator in place \> 3 months

• Intrinsic or biventricular paced QRS duration of \<= 120 milliseconds

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Contact Information
Primary
Denice Hodgson-Zingman, MD
denice-zingman@uiowa.edu
+1 319 384 2915
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 52
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Cleveland Clinic, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Denice Hodgson-Zingman, MD

This content was sourced from clinicaltrials.gov