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Behavioral Intervention

Cardiac Rehabilitation for Cardiac Amyloidosis (CAPACITY Trial)

N/A
Recruiting
Led By Jai Singh, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18
New York Heart Association (NYHA) Class I-III Heart Failure
Must not have
Gait instability or history of prior falls
NYHA Class IV Heart Failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial showed exercise training helps people with heart failure and preserved ejection fraction improve their cardiorespiratory fitness and quality of life.

Who is the study for?
The CAPACITY study is for adults over 18 with mild to moderate heart failure who can exercise and commit to a cardiac rehab program. They should be on stable treatment or monitored for cardiac amyloidosis, have a life expectancy of at least 6 months, and be able to attend thrice-weekly sessions.
What is being tested?
This trial tests the benefits of a structured exercise program (cardiac rehabilitation) in patients with heart failure who still have normal heart pumping function. It aims to see if their fitness and quality of life improve with regular supervised exercise.
What are the potential side effects?
While not drug-related, potential side effects from participating in this trial may include typical risks associated with physical activity such as muscle soreness, fatigue, or exacerbation of underlying heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have heart failure but can still perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have trouble walking or have fallen before.
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I have severe heart failure.
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I cannot commit to 3 weekly in-person exercise sessions for 12 weeks.
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I need home oxygen for my lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants that complete at least 75% of prescribed cardiac rehab sessions
Secondary study objectives
Change in cardiorespiratory fitness - 6-minute walk test distance
Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates
Change in cardiorespiratory fitness - chronotropic incompetence scores
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: cardiac rehabilitation groupExperimental Treatment1 Intervention
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.
Group II: control group - no interventionActive Control1 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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,657 Total Patients Enrolled
Jai Singh, MDPrincipal InvestigatorWake Forest University Health Sciences
~26 spots leftby Jul 2025
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