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Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

Sponsor: University Hospital, Montpellier • ClinicalTrials.gov ID: NCT07494942

Registry updated: 2026-10-08

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Description

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

Cardiac Rehabilitation Program (Behavioral)
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.

Eligibility criteria

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

Conditions

Amyloidosis

Locations

KRIEF — Montpellier, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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