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

March 26, 2026 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in peak oxygen uptake
Time Frame: Baseline (Day 15)
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
Time Frame: Day 90
Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.
Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in exercise capacity parameters
Time Frame: Baseline (Day 15)
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
Time Frame: Day 90
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
Time Frame: Baseline (Day 15)
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Baseline (Day 15)
Change in cardiac output
Time Frame: Day 90
Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.
Day 90
Change in autonomic function
Time Frame: Baseline (Day 15)
Assessment of dysautonomia using heart rate variability measurements.
Baseline (Day 15)
Change in autonomic function
Time Frame: Day 90
Assessment of dysautonomia using heart rate variability measurements.
Day 90
Presence of orthostatic hypotension
Time Frame: Baseline (Day 15)
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Baseline (Day 15)
Presence of orthostatic hypotension
Time Frame: Day 90
Evaluation of orthostatic blood pressure response before and after the rehabilitation program.
Day 90
Change in NT-proBNP
Time Frame: Baseline (Day 15)
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
Time Frame: Day 90
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
Time Frame: During the 5-week cardiac rehabilitation period
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
Time Frame: Baseline (Day 15)

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
Time Frame: Day 90

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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