Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Location status: Recruiting
NCT Number: NCT06096675
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charlotte, North Carolina, 28204, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: supervised cardiac rehabilitation sessions
Time frame: Week 12
Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions.
Time frame: Week 12
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.
Time frame: Week 12
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).
Time frame: Week 12
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.
Time frame: Week 12
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).
Time frame: Week 12
In healthy subjects, the 6-min walk distance (6MWD) ranges from 400 to 700 m, the main predictor variables being gender, age and height.
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
Acronym: CAPACITY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07215715
ATTR-CM (Transthyretin Amyloid Cardiomyopathy), Amyloid Neuropathies
Boston, Massachusetts, United States
View Trial DetailsNCT06610019
Amyloid Neuropathies, Amyloid Neuropathies, Familial
The Bronx, New York, United States
View Trial DetailsNCT05593679
Amyloid Neuropathies, Amyloid Neuropathies, Familial
New Taipei City, Taiwan
View Trial DetailsNCT06129656
Amyloid Neuropathies, Amyloid Neuropathies, Familial
Leipzig, Saxony, Germany
View Trial Details