Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis

NCT07494942 | Not Yet Recruiting

• 1 other identifier: RECHMPL25_0237
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyloidosis

Keywords

Cardiac Amyloidosis; Cardiac Rehabilitation; Heart Failure; ATTR Amyloidosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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)

Study Arms (1)

Cardiac Rehabilitation Program

EXPERIMENTAL

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

Interventions

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.

Cardiac Rehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

KRIEF

Montpellier, France

Location

MeSH Terms

Conditions

Amyloidosis; Amyloid Neuropathies, Familial; Heart Failure

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Susan Martinez, PhD

CONTACT

04 67 33 52 56; s-martinezjahnke@chu-montpellier.fr

Johanna KRIEF, Dr

CONTACT

06 59 42 43 73; j-krief@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a single-group, before-after design in which all participants receive the structured cardiac rehabilitation program. Outcomes are measured at baseline and again several weeks after the intervention. Each participant serves as their own comparator to evaluate changes attributable to the rehabilitation program.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)