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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met