Back to resultsCAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study (CAPACITY)
Primary Purpose
Cardiac Amyloidosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
• Cardiac Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiac Amyloidosis focused on measuring heart failure, preserved ejection fraction, cardiac rehabilitation
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.
Sites / Locations
- Sanger Heart and Vascular Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cardiac rehabilitation group
control group - no intervention
Arm 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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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).
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.
Full Information
NCT ID
NCT06096675
First Posted
October 17, 2023
Last Updated
October 24, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06096675
Brief Title
CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study
Acronym
CAPACITY
Official Title
Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
Keywords
heart failure, preserved ejection fraction, cardiac rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cardiac rehabilitation group
Arm Type
Experimental
Arm 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.
Arm Title
control group - no intervention
Arm Type
No Intervention
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
• Cardiac Rehabilitation
Other Intervention Name(s)
supervised cardiac rehabilitation sessions
Intervention 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.
Primary Outcome Measure Information:
Title
Number of participants that complete at least 75% of prescribed cardiac rehab sessions
Description
Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in cardiorespiratory fitness - maximal VO2 rates
Description
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
Title
Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates
Description
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
Title
Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores
Description
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
Title
Change in cardiorespiratory fitness - chronotropic incompetence scores
Description
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
Title
Change in cardiorespiratory fitness - 6-minute walk test distance
Description
In healthy subjects, the 6-min walk distance (6MWD) ranges from 400 to 700 m, the main predictor variables being gender, age and height.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana B Amaro, RN
Phone
704-355-4692
Email
Dana.Amaro@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Singh, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana B Amaro, RN
Phone
704-355-4692
Email
Dana.Amaro@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Jai Singh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study
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