RecruitingNot ApplicableNCT06096675

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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.

Interventions

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(1)

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

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NCT06096675


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