Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT07583823

Conditions

Cardiac Amyloidosis

Pacemaker

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pacemaker Rate

Study Details

Brief summary:

This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.

Conditions

Cardiac Amyloidosis

Pacemaker

Study ID

NCT07583823

Start date

Oct 10, 2025

Status verified date

May, 2026

Completion date

Oct 10, 2026

Anticipated

Primary completion date

Oct 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Elevated Pacemaker Rate

CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.

Interventions

Pacemaker Rate

CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.

Primary outcome measure

  • Kansas City Cardiomyopathy Questionnaire Score [ Time Frame: Month 4 ]
  • Composite of any cardiovascular event [ Time Frame: Month 4 ]

Central Contacts and Locations

Central contacts

Meghan Muscala

612-626-5863payne324@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Meghan Muscala

612-626-5863payne324@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-13.