CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

NCT06096675 | Recruiting

• 1 other identifier: IRB00095189
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Keywords

heart failure; preserved ejection fraction; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in cardiorespiratory fitness - maximal VO2 rates

  Week 12

• Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates

  Week 12

• Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores

  Week 12

• Change in cardiorespiratory fitness - chronotropic incompetence scores

  Week 12

• Change in cardiorespiratory fitness - 6-minute walk test distance

  Week 12

Study Arms (2)

cardiac rehabilitation group

EXPERIMENTAL

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

control group - no intervention

NO INTERVENTION

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

Interventions

• Cardiac Rehabilitation BEHAVIORAL

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.

Also known as: supervised cardiac rehabilitation sessions

cardiac rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jai Singh, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana B Amaro, RN

CONTACT

704-355-4692; Dana.Amaro@atriumhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrollment in supervised cardiac rehabilitation for 3 one-hour sessions a week for a total of 12 weeks (36 sessions)

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: January 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)