Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06096675

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Led by Wake Forest University Health Sciences · Updated on 2025-07-28

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of supervised cardiac rehabilitation exercise programs in patients with cardiac amyloidosis, a condition affecting heart function. The study aims to assess whether structured exercise can improve cardiorespiratory fitness and quality of life in these patients, focusing on those with heart failure classified as New York Heart Association Class I-III. This pilot study also intends to inform future treatment options and insurance coverage for cardiac rehabilitation in cancer and non-cancer populations. Participants are randomly assigned to one of two groups. The intervention group undergoes baseline fitness tests including a 6-minute walk test and cardiopulmonary exercise test (CPET), followed by a supervised cardiac rehabilitation program consisting of three one-hour exercise sessions per week for 12 weeks, totaling 36 sessions. After completing the program, these tests are repeated. The control group completes the same baseline tests but does not participate in the rehabilitation program and repeats the tests after 12 to 14 weeks. During the study, participants will be monitored for their ability to complete at least 75% of the prescribed exercise sessions. Researchers will measure changes in maximal oxygen uptake, ventilatory efficiency, exercise capacity via walk tests, chronotropic competence, and quality of life using the Kansas City Cardiomyopathy Questionnaire. The total participation includes initial assessments, the 12-week intervention or observation period, and follow-up testing within two weeks after program completion to evaluate outcomes and adherence.

CONDITIONS

Brief Title

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • New York Heart Association (NYHA) Class I-III Heart Failure
  • Able to exercise
  • On stable treatment for cardiac amyloidosis or under active surveillance
  • Life expectancy of at least 6 months
  • Able to understand and willing to sign informed consent in English
  • Willing and able to follow cardiac rehabilitation activities
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Unable to commit to in-person supervised exercise sessions three times a week for 12 weeks
  • NYHA Class IV Heart Failure
  • Pulmonary disease requiring home oxygen
  • Gait instability or history of prior falls
  • Clinically significant comorbid disease interfering with study participation as judged by the Principal Investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants undergo a supervised cardiac rehabilitation program consisting of planned 3 one-hour exercise sessions per week for a total of 12 weeks.

Approximately 36 supervised exercise sessions (3 times per week)

Outpatient Treatment

Duration - 12 to 14 weeks

Participants who do not receive the intervention will have baseline and follow-up tests without exercise sessions over approximately 12 to 14 weeks.

2 visits (baseline and follow-up testing)

Trial Site Locations

Total: 1 location

1

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

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Research Team

D

Dana B Amaro, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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