RECRUITING

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Conditions

Cardiac Amyloidosis heart failure preserved ejection fraction cardiac rehabilitation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

Quick Facts

Study Start:2024-01-22

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06096675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Dana B Amaro, RN

CONTACT

704-355-4692

Dana.Amaro@atriumhealth.org

Principal Investigator

Jai Singh, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Jai Singh, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-22

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

heart failure
preserved ejection fraction
cardiac rehabilitation

Additional Relevant MeSH Terms

Cardiac Amyloidosis