Amyloidosis
Conditions
Keywords
Cardiac Amyloidosis, Cardiac Rehabilitation, Heart Failure, ATTR Amyloidosis
Brief 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.
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.
Interventions
BEHAVIORALCardiac 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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak oxygen uptake | Baseline (Day 15) | Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity parameters | Baseline (Day 15) | 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 |
| Change in cardiac output | Baseline (Day 15) | Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation. |
| Change in autonomic function | Baseline (Day 15) | Assessment of dysautonomia using heart rate variability measurements. |
| Presence of orthostatic hypotension | Baseline (Day 15) | Evaluation of orthostatic blood pressure response before and after the rehabilitation program. |
| Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire | Baseline (Day 15) | 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. |
| Change in NT-proBNP | Baseline (Day 15) | Variation in NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) concentration measured before and after the rehabilitation program. |
| Safety of cardiac rehabilitation | During the 5-week cardiac rehabilitation period | 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 |
Countries
France
Contacts
CONTACTSusan Martinez, PhD
CONTACTJohanna KRIEF, Dr
Outcome results
None listed