NCT07494942

Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-01-30
• Completion: 2029-01-30
• First posted: 2026-03-27
• Last updated: 2026-04-01

Locations

1 site across 1 country: France