Recruiting

Cardiac Amyloidosis

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06096675

Conditions

Cardiac Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

• Cardiac Rehabilitation

Study Details

Brief 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.

Conditions

Cardiac Amyloidosis

Study ID

NCT06096675

Start date

Jan 22, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: cardiac rehabilitation group

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.

no intervention: control group - no 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

Interventions

• 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.

Primary outcome measure

  • Number of participants that complete at least 75% of prescribed cardiac rehab sessions [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Dana B Amaro, RN

704-355-4692Dana.Amaro@atriumhealth.org

Locations

Sanger Heart and Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Dana B Amaro, RN

704-355-4692Dana.Amaro@atriumhealth.org

Principal Investigator:

Jai Singh, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • heart failure
  • preserved ejection fraction
  • cardiac rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.