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Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

ConditionAmyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiac Rehabilitation Program

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Cardiac Rehabilitation ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in peak oxygen uptake

Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.

Time frame
Baseline (Day 15)
2

Change in peak oxygen uptake

Change in VO₂ peak (ml/min/kg) measured before and after completion of the cardiac rehabilitation program.

Time frame
Day 90

Secondary outcomes

1

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

Time frame
Baseline (Day 15)
2

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

Time frame
Day 90
3

Change in cardiac output

Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.

Time frame
Baseline (Day 15)
4

Change in cardiac output

Variation in cardiac output estimated by impedance cardiography (PhysioFlow) before and after rehabilitation.

Time frame
Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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