Elevated Rate Pacing of Cardiac Amyloidosis

NCT07583823 | Recruiting FDA Device

• 1 other identifier: CV-2025-33753
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Kansas City Cardiomyopathy Questionnaire Score

  75-100 representing good to excellent health, and 0-24 representing very poor to poor health

  Month 4

• Composite of any cardiovascular event

  admission or urgent visit for heart failure and atrial fibrillation, myocardial infarction or stroke

  Month 4

Study Arms (1)

Elevated Pacemaker Rate

EXPERIMENTAL

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

Other: Pacemaker Rate

Interventions

Pacemaker Rate OTHER

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

Elevated Pacemaker Rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Paced QRS duration of \>150 ms (indicator for pacing mediated dyssynchrony)
• Dilated left ventricle

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Valmiki Maharaj

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Muscala

CONTACT

612-626-5863; payne324@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)