CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Wake Forest University (WFU)

Status: Enrolling

Conditions: Cardiac Amyloidosis

Treatments: Behavioral: • Cardiac Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06096675

IRB00095189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

cardiac rehabilitation group

Experimental group

Description:

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.

Treatment:

Behavioral: • Cardiac Rehabilitation

control group - no intervention

No Intervention group

Description:

Control Group will have baseline 6-minute walk test and CPET testing followed by a repeat 6-minute walk test and CPET test in 12-14 weeks