Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cardiac Rehabilitation Program
Participants receive a structured 5-week cardiac rehabilitation program delivered in a specialized center. The program includes two supervised sessions per day, five days per week, combining aerobic training and muscle strengthening. The rehabilitation is provided by a multidisciplinary team experienced in heart failure and functional evaluation.
干预措施: Cardiac Rehabilitation Program (Behavioral)
结局指标
主要结局
Change in peak oxygen uptake
时间窗: Baseline (Day 15)
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
Change in peak oxygen uptake
时间窗: Day 90
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
次要结局
- Change in exercise capacity parameters(Baseline (Day 15))
- Change in exercise capacity parameters(Day 90)
- Change in cardiac output(Baseline (Day 15))
- Change in cardiac output(Day 90)
- Change in autonomic function(Baseline (Day 15))
- Change in autonomic function(Day 90)
- Presence of orthostatic hypotension(Baseline (Day 15))
- Presence of orthostatic hypotension(Day 90)
- 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(Day 90)
- Change in NT-proBNP(Baseline (Day 15))
- Change in NT-proBNP(Day 90)
- Safety of cardiac rehabilitation(During the 5-week cardiac rehabilitation period)