Clinical trial NCT06096675: CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study
Official title: Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Amyloidosis
Keywords: heart failure
preserved ejection fraction
cardiac rehabilitation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrollment in supervised cardiac rehabilitation for 3 one-hour sessions a week for a total of 12 weeks (36 sessions)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Primary outcomes:
measure: Number of participants that complete at least 75% of prescribed cardiac rehab sessions
timeFrame: Week 12
Secondary outcomes:
measure: Change in cardiorespiratory fitness - maximal VO2 rates
timeFrame: Week 12
measure: Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates
timeFrame: Week 12
measure: Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores
timeFrame: Week 12
measure: Change in cardiorespiratory fitness - chronotropic incompetence scores
timeFrame: Week 12
measure: Change in cardiorespiratory fitness - 6-minute walk test distance
timeFrame: Week 12
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jai Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: