CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Conditions
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Cardiac Amyloidosis

Intervention / Treatment
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* Behavioral: • Cardiac Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrollment in supervised cardiac rehabilitation for 3 one-hour sessions a week for a total of 12 weeks (36 sessions)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac rehabilitation group<br>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. | Behavioral: • Cardiac Rehabilitation<br>* 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.<br>* Other names: supervised cardiac rehabilitation sessions;|
| No Intervention: control group - no intervention<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that complete at least 75% of prescribed cardiac rehab sessions | Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory fitness - maximal VO2 rates | Change in cardiorespiratory fitness as assessed by maximal (max) rate (V) of oxygen (O₂) your body is able to use during exercise VO2 (ml/kg/min ) on cardiopulmonary exercise test (CPET). Vo2 Max scores can vary based on a number of factors in addition to fitness, such as your gender, age and genetics, but a vo2 max measurement for an average person in their mid 30s to mid 40s is likely to be around: Women - 31 ml oxygen/kg of body weight/minute. Men - 42 ml oxygen/kg of body weight/minute. | Week 12 | 
| Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates | Ventilatory equivalent for carbon dioxide ( ˙VE/ ˙VCO2) identifies the second ventilatory threshold, namely, the point in time when ventilatory drive starts increasing relative to ˙VCO2 (i.e., when hyperventilation occurs). | Week 12 | 
| Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores | KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. | Week 12 | 
| Change in cardiorespiratory fitness - chronotropic incompetence scores | the inability of the heart to increase its rate commensurate with increased activity or demand, is common in patients with cardiovascular disease, produces exercise intolerance which impairs quality-of-life - chronotropic incompetence is usually defined as failure to achieve a chronotropic index of 0.8 or higher (i.e., falling below 97.5 percent of healthy adults). | Week 12 | 
| Change in cardiorespiratory fitness - 6-minute walk test distance | In healthy subjects, the 6-min walk distance (6MWD) ranges from 400 to 700 m, the main predictor variables being gender, age and height. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, preserved ejection fraction, cardiac rehabilitation