CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Cardiac Amyloidosis Clinical Trial

— CAPACITY  

Official title:

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096675
• Other study ID #: IRB00095189
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: January 2025

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: Dana B Amaro, RN
• Phone: 704-355-4692
• Email: Dana.Amaro[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

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.

Locations

Country	Name	City	State
United States	Sanger Heart and Vascular Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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