Elevated Rate Pacing of Cardiac Amyloidosis

May 6, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elevated Pacemaker Rate
CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.
Other: Pacemaker Rate
CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kansas City Cardiomyopathy Questionnaire Score
Time Frame: Month 4
75-100 representing good to excellent health, and 0-24 representing very poor to poor health
Month 4
Composite of any cardiovascular event
Time Frame: Month 4
admission or urgent visit for heart failure and atrial fibrillation, myocardial infarction or stroke
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Valmiki Maharaj, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-2025-33753

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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