Exercise program for patients with cardiac amyloidosis
Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
NA · Wake Forest University Health Sciences · NCT06096675
This study tests whether a supervised exercise program can help people with cardiac amyloidosis and heart failure feel better and improve their heart health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT06096675 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a supervised exercise program on patients with cardiac amyloidosis and heart failure with preserved ejection fraction (HFpEF). The Atrium Health cardiac rehabilitation program aims to improve cardiac performance and quality of life through structured exercise sessions. Participants will engage in three one-hour sessions per week for 12 weeks, focusing on enhancing their cardiorespiratory fitness. The study seeks to gather objective data to potentially expand cardiac rehabilitation eligibility for cancer patients in the future.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with NYHA Class I-III heart failure who are stable on treatment for cardiac amyloidosis.
Not a fit: Patients with NYHA Class IV heart failure or significant comorbidities that affect their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and cardiac function for patients with cardiac amyloidosis.
How similar studies have performed: Other studies have shown positive outcomes with supervised exercise programs in heart failure patients, suggesting a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Charlotte, North Carolina
- Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Jai Singh, MD — Wake Forest University Health Sciences
- Study coordinator: Dana B Amaro, RN
- Email: Dana.Amaro@atriumhealth.org
- Phone: 704-355-4692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Amyloidosis, heart failure, preserved ejection fraction, cardiac rehabilitation