Paced heart rate acceleration for improving heart function
A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection
This study is testing if a special heart pacing treatment that mimics exercise can help people with systolic heart failure feel better and improve their heart function compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06332391 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of exercise-similar heart rate acceleration delivered through cardiac pacing compared to a sham intervention in patients with systolic heart failure. The study involves 52 participants who will be randomly assigned to receive either the pacing intervention or a sham treatment three times a week for six weeks. The trial aims to assess changes in symptoms, functional capacity, and heart structure by measuring various clinical outcomes before, during, and after the intervention period. The research is conducted at the University of Iowa, with statistical analysis performed by the Cleveland Clinic.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with systolic heart failure and an existing implantable cardioverter defibrillator.
Not a fit: Patients with severe mobility limitations or significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cardiac conditioning and improve the quality of life for patients with heart failure.
How similar studies have performed: While similar pacing interventions have been explored, this specific approach to mimic exercise patterns through pacing is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Age \< 18 years * Inability to ambulate safely * Congenital or primary valve disease * Ongoing (not suppressed) atrial arrhythmias * Left ventricular thrombus * Severe peripheral arterial disease that limits mobility * Hospital admission for life-threatening condition (e.g. heart failure, stroke) in the past 3 months * Major surgery in the past 3 months or anticipated during the period of study * Ventricular pacing indication in the absence of biventricular pacing * Life expectancy \< 1 year * Hemodialysis * Hematocrit \< 30% * Severe chronic lung disease that limits activity or requires oxygen * Pregnancy * Implantable cardioverter defibrillator battery longevity \< 1 year * Vulnerable populations such as prisoners and institutionalized individuals
Where this trial is running
Iowa City, Iowa
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Denice Hodgson-Zingman, MD — University of Iowa
- Study coordinator: Denice Hodgson-Zingman, MD
- Email: denice-zingman@uiowa.edu
- Phone: +1 319 384 2915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.