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CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The CAPACITY study looks at exercise in adults with cardiac amyloidosis, a buildup of abnormal protein in the heart, who have heart failure. Exercise training has been linked to better fitness and quality of life in people with heart failure whose hearts still pump a normal share of blood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have heart failure in NYHA Class I–III, meaning you have no symptoms or some symptoms during activity.
  • You can exercise.
  • Your heart amyloidosis treatment is stable, or your care team is closely watching your condition.
  • You are expected to live at least 6 months.
  • You can understand and are willing to sign an English form agreeing to join the study.
  • You can and will follow the study plan, including the heart exercise program.

Who can't join

  • You cannot give informed consent, meaning you cannot agree to join after understanding the study.
  • You cannot attend supervised exercise in person for three one-hour sessions each week for 12 weeks.
  • You have NYHA Class IV heart failure, meaning you have symptoms even at rest.
  • You have lung disease that requires oxygen at home.
  • You are unsteady when walking or have fallen in the past.
  • The lead study doctor thinks another serious illness could keep you from finishing the study or affect how you report your health.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NC