AmyloidosisRECARDANCT07494942
Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
A study testing Cardiac Rehabilitation Program in people with Amyloidosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Cardiac Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2026to 23 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
KRIEF
Montpellier
Johanna KRIEF, Dr, 06 59 42 43 73, j-krief@chu-montpellier.fr
Jérôme ADDA, Dr, adda.jerome@gmail.com
About this study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Amyloidosis
- Being tested
- Cardiac Rehabilitation Program
- Keywords
- Cardiac Amyloidosis, Cardiac Rehabilitation, Heart Failure, ATTR Amyloidosis
- Medical subject headings
- Amyloidosis, Amyloid Neuropathies, Familial, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Program | Experimental | 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. Receives: Behavioral: Cardiac Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
Measured: 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.
Measured: Day 90
Secondary outcomes (13)
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
Measured: 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
Measured: Day 90
Change in cardiac output
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Measured: Baseline (Day 15)
Change in cardiac output
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Measured: Day 90
Change in autonomic function
Assessment of dysautonomia using heart rate variability measurements.
Measured: Baseline (Day 15)
Change in autonomic function
Assessment of dysautonomia using heart rate variability measurements.
Measured: Day 90
Presence of orthostatic hypotension
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Measured: Baseline (Day 15)
Presence of orthostatic hypotension
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: During the 5-week cardiac rehabilitation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Sep 2026
- Primary completion23 Sep 2029 (estimated)
- Study completion23 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group, before-after design in which all participants receive the structured cardiac rehabilitation program. Outcomes are measured at baseline and again several weeks after the intervention. Each participant serves as their own comparator to evaluate changes attributable to the rehabilitation program.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494942
- Sponsor's protocol ID
- RECHMPL25_0237
- Acronym
- RECARDA
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No