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Recruiting NCT06096675

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

No phase Interventional Cardiac Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: • Cardiac Rehabilitation.
Who it may be relevant to
Registry conditions: Cardiac Amyloidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Overview

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.

Detailed 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.

Interventions

  • Behavioral • Cardiac Rehabilitation
    Intervention group will have baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing followed by supervised cardiac rehabilitation program including planned 3 one hour sessions a week for a total of 12 weeks (planned 36 sessions). A post intervention 6-minute walk test and CPET test will be performed within 2 weeks of completion of the 12 week program.

Primary outcome measures

  • Number of participants that complete at least 75% of prescribed cardiac rehab sessions [Time frame: Week 12]
Secondary outcome measures (5)
  • Change in cardiorespiratory fitness - maximal VO2 rates [Time frame: Week 12]
  • Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates [Time frame: Week 12]
  • Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores [Time frame: Week 12]
  • Change in cardiorespiratory fitness - chronotropic incompetence scores [Time frame: Week 12]
  • Change in cardiorespiratory fitness - 6-minute walk test distance [Time frame: Week 12]

Eligibility criteria

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 consent document in English, and the willingness/ability to comply with the protocol activities
  • Participant must be able and willing to follow the cardiac rehabilitation activities

Exclusion criteria

  • Inability to provide informed consent
  • Inability to commit to in-person supervised exercise sessions for three one-hour sessions 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 comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Sanger Heart and Vascular Institute — Charlotte

Identifiers

NCT: NCT06096675 · IRB00095189

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗