Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

Overview

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

• 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

Primary outcome measures

• Change in peak oxygen uptake [Time frame: Baseline (Day 15)]
• Change in peak oxygen uptake [Time frame: Day 90]

Secondary outcome measures (12)

• Change in exercise capacity parameters [Time frame: Baseline (Day 15)]
• Change in exercise capacity parameters [Time frame: Day 90]
• Change in cardiac output [Time frame: Baseline (Day 15)]
• Change in cardiac output [Time frame: Day 90]
• Change in autonomic function [Time frame: Baseline (Day 15)]
• Change in autonomic function [Time frame: Day 90]
• Presence of orthostatic hypotension [Time frame: Baseline (Day 15)]
• Presence of orthostatic hypotension [Time frame: Day 90]
• Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire [Time frame: Baseline (Day 15)]
• Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire [Time frame: Day 90]
• Change in NT-proBNP [Time frame: Baseline (Day 15)]
• Change in NT-proBNP [Time frame: Day 90]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• KRIEF — Montpellier

Identifiers

NCT: NCT07494942 · RECHMPL25_0237

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗