CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Last updated: July 25, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Treatment

• Cardiac Rehabilitation

Clinical Study ID

NCT06096675
IRB00095189
  • Ages > 18
  • All Genders

Study Summary

Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18

  • New York Heart Association (NYHA) Class I-III Heart Failure

  • Able to Exercise

  • On stable treatment for their cardiac amyloidosis or under active surveillance

  • Life expectancy of at least 6 months

  • Ability to understand and the willingness to sign a written informed consentdocument in English, and the willingness/ability to comply with the protocolactivities

  • Participant must be able and willing to follow the cardiac rehabilitation activities

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent

  • Inability to commit to in-person supervised exercise sessions for three one-hoursessions a week for 12 weeks

  • NYHA Class IV Heart Failure

  • Pulmonary disease requiring home oxygen

  • Gait instability or history of prior falls

  • In the opinion of the Principal Investigator, have a clinically significant comorbiddisease that is likely to affect the ability of the patient to complete the trial,interfere with their ability with measurement of self-reported outcomes.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: • Cardiac Rehabilitation
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
June 30, 2027

Study Description

The Atrium Health cardiac rehabilitation program delivers a comprehensive approach to improve cardiac performance including supervised exercise programs and has the ideal infrastructure to offer cardio-oncology rehabilitation (CORE) to all our cancer patients in the future. Currently neither CORE nor cardiac rehabilitation for HFpEF are covered by insurance, and hence the targeting of a higher risk cancer and non-cancer population of cardiac amyloidosis patients to objectively measure the benefits of a supervised exercise program ultimately to expand eligibility to all cancer patients and shape the treatment and payor landscape in the future.

Connect with a study center

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.