Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change in peak oxygen uptake [Срок оценки: Baseline (Day 15)]
• Change in peak oxygen uptake [Срок оценки: Day 90]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• KRIEF — Montpellier

Идентификаторы

NCT: NCT07494942 · RECHMPL25_0237

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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