NCT06332391Recruiting
Paced Heart Rate Acceleration for Cardiac Conditioning
A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- Jun 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Denice Hodgson-Zingman, MD
- Diseases
- Heart failure
- NCT number
- NCT06332391
What you commit to
- Study type: Interventional
- Planned participants: 52
- From Jun 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery in the past 3 months or anticipated during the period of study
Other illness
- 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
- Age \< 18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.