Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis (NCT07494942) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
France40 participantsStarted 2026-04-30
Plain-language summary
The goal of this clinical trial is to learn if a structured cardiac rehabilitation program can help people with cardiac amyloidosis improve their ability to exercise and their quality of life. The main questions it aims to answer are:
Does cardiac rehabilitation raise peak oxygen uptake (VO₂ peak), which shows how well the heart and lungs work during exercise? Is cardiac rehabilitation safe and practical for people with cardiac amyloidosis? How does cardiac rehabilitation affect other exercise measures, heart function, symptoms linked to autonomic dysfunction, and quality of life?
This study has no comparison group. Researchers will measure each participant's results before and after the rehabilitation program.
Participants will:
Complete a cardiac rehabilitation program for 5 weeks. Have tests before the program starts and again about 3 months later. These tests include:
A cardiopulmonary exercise test A heart function test using electrical impedance A questionnaire about quality of life A blood sample A blood pressure test to check for orthostatic hypotension
The study will include adults aged 18 or older with transthyretin cardiac amyloidosis who are able to perform an exercise test.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Cardiac ATTR amyloidosis diagnosed according to guidelines: Perugini grade II or III uptake on bone scintigraphy, without monoclonal gammopathy.
* Ability to undergo a stress test
* Available to complete the 5-week rehabilitation program within 30 days of the stress test
Exclusion Criteria:
* Uncontrolled ventricular arrhythmias
* NYHA Class IV heart failure
* Inability to give informed consent to participate in the study
* Inability to monitor the patient during the study period
* Subject not enrolled in a social security program or not eligible for such a program
* Pregnant or breastfeeding women, patients unable to give consent, protected adults, vulnerable persons
* Subjects deprived of liberty by judicial or administrative decision
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.