Higher pacemaker rate for people with cardiac amyloidosis
Elevated Rate Pacing of Cardiac Amyloidosis
This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07583823 on ClinicalTrials.gov |
What this trial studies
This single-center interventional pilot will enroll 10 adults with cardiac amyloidosis who have implanted pacemakers. Investigators will temporarily raise the programmed pacing rate and compare heart-failure symptoms and exercise tolerance before and after the rate change. Eligible patients must have a non-dilated left ventricle and appropriate pacemaker modes (AAI, DDD, or VVI for permanent atrial fibrillation), while those with paced QRS >150 ms or a dilated LV are excluded. All procedures and outcome measurements are performed in person at the University of Minnesota using standardized symptom and exercise assessments.
Who should consider this trial
Good fit: Adults (≥18) with confirmed cardiac amyloidosis, an implanted pacemaker set to AAI/DDD or VVI as applicable, a non-dilated left ventricle, and the ability to consent and attend visits at the University of Minnesota are ideal candidates.
Not a fit: Patients with a dilated left ventricle, a paced QRS duration greater than 150 ms, or those unable to travel to Minneapolis or communicate in English are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, this approach could offer a simple pacemaker-based way to improve symptoms and exercise capacity for some patients with cardiac amyloidosis.
How similar studies have performed: Pacing-rate adjustments have been explored in other types of heart failure, but deliberately raising paced rate specifically in cardiac amyloidosis is a small, relatively novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 and older * Diagnosis of cardiac amyloidosis as indicated by the criteria set forth in guidelines such as in Kittleson et al: "2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis: A Report of the American College of Cardiology Solution Set Oversight Committee * Implanted Cardiac Pacemaker (+/- Defibrillator) * Pacemaker mode of AAI or DDD if in sinus rhythm, VVI acceptable if permanent atrial fibrillation * Non-dilated left ventricle by echocardiography * Ability to provide written consent * English Speaking Exclusion Criteria: * Paced QRS duration of \>150 ms (indicator for pacing mediated dyssynchrony) * Dilated left ventricle
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Valmiki Maharaj — University of Minnesota
- Study coordinator: Meghan Muscala
- Email: payne324@umn.edu
- Phone: 612-626-5863
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.