Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis (RECARDA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amyloidosis
• Intervention / Treatment: Behavioral: Cardiac Rehabilitation Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Martinez, PhD; Phone Number: 04 67 33 52 56; Email: s-martinezjahnke@chu-montpellier.fr
• Study Contact Backup: Name: Johanna KRIEF, Dr; Phone Number: 06 59 42 43 73; Email: j-krief@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • KRIEF
    • Contact: Johanna KRIEF, Dr; Phone Number: 06 59 42 43 73; Email: j-krief@chu-montpellier.fr
    • Contact: Jérôme ADDA, Dr; Email: adda.jerome@gmail.com
    • Principal Investigator: Johanna KRIEF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak oxygen uptake	Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.	Baseline (Day 15)
Change in peak oxygen uptake	Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise capacity parameters	Changes in VE/VCO₂ (Ventilatory Equivalent for Carbon Dioxide) slope, oxygen pulse, maximal workload, achieved heart rate, and VO₂ at first ventilatory threshold before and after rehabilitation	Baseline (Day 15)
Change in exercise capacity parameters	Changes in VE/VCO₂ (Ventilatory Equivalent for Carbon Dioxide) slope, oxygen pulse, maximal workload, achieved heart rate, and VO₂ at first ventilatory threshold before and after rehabilitation	Day 90
Change in cardiac output	Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.	Baseline (Day 15)
Change in cardiac output	Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.	Day 90
Change in autonomic function	Assessment of dysautonomia using heart rate variability measurements.	Baseline (Day 15)
Change in autonomic function	Assessment of dysautonomia using heart rate variability measurements.	Day 90
Presence of orthostatic hypotension	Evaluation of orthostatic blood pressure response before and after the rehabilitation program.	Baseline (Day 15)
Presence of orthostatic hypotension	Evaluation of orthostatic blood pressure response before and after the rehabilitation program.	Day 90
Change in NT-proBNP	Variation in NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) concentration measured before and after the rehabilitation program.	Baseline (Day 15)
Change in NT-proBNP	Variation in NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) concentration measured before and after the rehabilitation program.	Day 90
Safety of cardiac rehabilitation	Monitoring of adverse events occurring during the 5-week rehabilitation, including exercise-related or post-exercise syncope, persistent hypotension, atrial or ventricular arrhythmias, conduction disorders, worsening dyspnea, or heart failure decompensation	During the 5-week cardiac rehabilitation period
Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire	Change in quality-of-life score using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.	Baseline (Day 15)
Change in quality of life score using the Kansas City Cardiomyopathy Questionnaire	Change in quality-of-life score using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.	Day 90

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): January 30, 2029

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Rehabilitation; Cardiac Amyloidosis; ATTR Amyloidosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Heart Diseases; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Amyloid Neuropathies; Amyloidosis, Familial; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Heart Failure; Amyloidosis; Amyloid Neuropathies, Familial
• Other Study ID Numbers: RECHMPL25_0237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No