An interventional study of Cardiac Rehabilitation Program in Amyloidosis, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
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.
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.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 189 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a structured 5-week cardiac rehabilitation program delivered in a specialized center. The program includes two supervised sessions per day, five days per week, combining aerobic training and muscle strengthening. The rehabilitation is provided by a multidisciplinary team experienced in heart failure and functional evaluation.
Behavioral: Cardiac Rehabilitation Program
Participants complete a structured 5-week cardiac rehabilitation program in a specialized center. They attend two supervised sessions per day, five days a week, combining individualized aerobic training (cycling or treadmill) with progressive intensity and strength exercises for major muscle groups. Each session includes warm-up and cool-down. Symptoms, blood pressure, and exercise tolerance are monitored daily to adjust the workload. A multidisciplinary team (cardiology, physiotherapy, exercise physiology, nursing) ensures continuous supervision. Educational support on physical activity and disease management is provided. The program is delivered either as inpatient or day-hospital care, depending on clinical needs.
Change in peak oxygen uptake
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
Time frame: Baseline (Day 15)
Change in peak oxygen uptake
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
Time frame: Day 90
Change in exercise capacity parameters
Changes in VE/VCO₂ (Ventilatory Equivalent for Carbon Dioxide) slope, oxygen pulse, maximal workload, achieved heart rate, and VO₂ at first ventilatory threshold before and after rehabilitation
Time frame: Baseline (Day 15)
Change in exercise capacity parameters
Changes in VE/VCO₂ (Ventilatory Equivalent for Carbon Dioxide) slope, oxygen pulse, maximal workload, achieved heart rate, and VO₂ at first ventilatory threshold before and after rehabilitation
Time frame: Day 90
Change in cardiac output
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Time frame: Baseline (Day 15)
Change in cardiac output
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Time frame: Day 90
Change in autonomic function
Assessment of dysautonomia using heart rate variability measurements.
Time frame: Baseline (Day 15)
Change in autonomic function
Assessment of dysautonomia using heart rate variability measurements.
Time frame: Day 90
Presence of orthostatic hypotension
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Time frame: Baseline (Day 15)
Presence of orthostatic hypotension
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Time frame: Day 90
Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire
Change in quality-of-life score using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.
Time frame: Baseline (Day 15)
Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire
Change in quality-of-life score using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.
Time frame: Day 90
Change in NT-proBNP
Variation in NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) concentration measured before and after the rehabilitation program.
Time frame: Baseline (Day 15)
Change in NT-proBNP
Variation in NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) concentration measured before and after the rehabilitation program.
Time frame: Day 90
Safety of cardiac rehabilitation
Monitoring of adverse events occurring during the 5-week rehabilitation, including exercise-related or post-exercise syncope, persistent hypotension, atrial or ventricular arrhythmias, conduction disorders, worsening dyspnea, or heart failure decompensation
Time frame: During the 5-week cardiac rehabilitation period
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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