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NCT Number: NCT07583823

Elevated Rate Pacing of Cardiac Amyloidosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Meghan Muscala

CONTACT

[email protected]

612-626-5863

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacemaker Rate

Other

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

Primary outcomes

  1. 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

  2. Composite of any cardiovascular event

    Time frame: Month 4

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

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan Muscala

CONTACT

[email protected]

612-626-5863

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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