ClinicalTrials.gov record NCT07494942
Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This single-group interventional study evaluates a supervised 5-week cardiac rehabilitation program in adults with transthyretin (ATTR) cardiac amyloidosis who can perform an exercise test. Participants attend two supervised sessions per day, five days a week, combining aerobic and strength training. Researchers measure exercise capacity, heart function, autonomic signs, quality of life, and blood tests before the program and again about three months later.
What it is studying. The study tests whether a structured 5-week cardiac rehabilitation program raises peak oxygen uptake (VO₂ peak), is safe and feasible for people with cardiac (ATTR) amyloidosis, and how it affects other exercise measurements, non-invasive cardiac output estimates, autonomic function, orthostatic blood pressure, and quality of life.
What the researchers hope to learn. To document the feasibility and safety of an intensive cardiac rehabilitation program in cardiac amyloidosis; to measure its effects on exercise capacity, cardiac function, autonomic regulation, orthostatic blood pressure, and patient-reported quality of life; and to identify participant profiles that could guide future multicenter randomized trials.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- Cardiac Rehabilitation Program
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Cardiac amyloidosis is a progressive restrictive heart disease that causes major limitations in exercise capacity, significant symptoms, and a marked reduction in quality of life. The number of diagnosed cases continues to rise, particularly among older adults. Despite this growing need, the role of cardiac rehabilitation in this population is not well established. Existing evidence comes mainly from small or heterogeneous studies, and no prospective study in France has systematically assessed its functional impact. This study was designed to address this gap by evaluating the effects of a structured cardiac rehabilitation program in a specialized setting. The five-week program (5 days a week, 2 sessions per day of aerobic exercise and strength training) includes supervised aerobic and strength-training sessions delivered by a multidisciplinary team experienced in heart failure and functional evaluation. Participants undergo standardized assessments before starting the program and several weeks after completion. These assessments focus on exercise tolerance, non-invasive cardiac function, autonomic regulation, and patient-reported quality of life. The study takes place in an expert center for cardiac amyloidosis with a large active cohort and comprehensive technical facilities. This environment provides optimal conditions for delivering an intensive and closely monitored rehabilitation program. The prospective design will help document the feasibility and overall functional effects of rehabilitation, as well as identify participant profiles that may derive the greatest benefit. The findings of this study are expected to clarify the role of cardiac rehabilitation in the management of cardiac amyloidosis and may support the development of a future multicenter randomized trial.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants complete a structured 5-week cardiac rehabilitation program (two supervised sessions per day, five days per week) combining individualized aerobic exercise (cycling or treadmill) and progressive strength training, delivered as inpatient or day-hospital care. Symptoms, blood pressure, and exercise tolerance are monitored daily and the program is supervised by a multidisciplinary team. Tests are done before the program and again about three months later and include a cardiopulmonary exercise test, non-invasive cardiac output measurement by impedance cardiography (PhysioFlow), orthostatic blood pressure checks, a blood sample, and a quality-of-life questionnaire. Safety is monitored during the 5-week program for events such as arrhythmias, persistent hypotension, syncope, worsening breathlessness, or heart-failure decompensation.
How the study is structured. Interventional, single-group, non-masked study: all participants take part in the same supervised 5-week cardiac rehabilitation program and are measured before the program and again about 3 months later. There is no comparison or control group. The primary purpose is supportive care/quality-of-life evaluation.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Amyloidosis. Does it apply to my diagnosis?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Sep 23, 2026
- Primary completion
- Sep 23, 2029 (estimated)
- Study completion
- Sep 23, 2029 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Oct 8, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Montpellier
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Susan Martinez, PhD 📞 04 67 33 52 56 ✉ s-martinezjahnke@chu-montpellier.fr
- Johanna KRIEF, Dr 📞 06 59 42 43 73 ✉ j-krief@chu-montpellier.fr
Participating sites (1)
- KRIEFRecruiting
Montpellier · France
- Johanna KRIEF, Dr · 06 59 42 43 73 · j-krief@chu-montpellier.fr
- Jérôme ADDA, Dr · adda.jerome@gmail.com
- Johanna KRIEF
Terms used on this page · explanations by MedicalUpdates.ai
- comparison group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials