Tests paced heart rate changes in people with heart failure
Tests a device that paces the heart like exercise in adults with systolic heart failure.
Plain-language title generated from the registry record
Registry title: Paced Heart Rate Acceleration for Cardiac Conditioning
Key facts
- Where
- Iowa City, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT06332391, who can take part
Where in United States
- University of Iowa Hospitals and ClinicsIowa City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Denice Hodgson-Zingman, MD
- Trial code
- NCT06332391
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection
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.
Inclusion: 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.
Exclusion: Major surgery in the past 3 months or anticipated during the period of study; Congenital or primary valve disease; Ongoing (not suppressed) atrial arrhythmias; Severe peripheral arterial disease that limits mobility; Hospital admission for life-threatening condition (e.g. heart failure, stroke) in the past 3 months; Severe chronic lung disease that limits activity or requires oxygen; Age < 18 years; Inability to ambulate safely; Left ventricular thrombus; Ventricular pacing indication in the absence of biventricular pacing; Life expectancy < 1 year; Hemodialysis; Hematocrit < 30%; Pregnancy; Implantable cardioverter defibrillator battery longevity < 1 year; Vulnerable populations such as prisoners and institutionalized individuals.