Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis
Cardiac Rehab Program for Cardiac Amyloidosis Patients
Plain English Summary
Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis is a Not Applicable clinical trial sponsored by University Hospital, Montpellier studying Amyloidosis. This trial tests if a structured cardiac rehabilitation program can improve exercise ability and quality of life for patients with cardiac amyloidosis. It is for adults aged 18 and older diagnosed with a specific type of cardiac amyloidosis (ATTR amyloidosis). Participants will complete a 5-week rehabilitation program and undergo tests before and after. Currently, there are no widely established cardiac rehabilitation programs specifically for this condition. The trial aims to enroll 40 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with ATTR cardiac amyloidosis. You must be able to perform a stress test and complete the 5-week program. You cannot join if you have uncontrolled heart rhythm problems, severe heart failure (NYHA Class IV), or are unable to give consent. Pregnant or breastfeeding women, and vulnerable individuals are also excluded. This trial is studying Amyloidosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well your heart and lungs work during exercise, aiming to see if the rehabilitation program helps you exercise better. The specific primary outcome measures are: Change in peak oxygen uptake (Baseline (Day 15)); Change in peak oxygen uptake (Day 90). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in care by investigating if a structured cardiac rehabilitation program can improve outcomes for patients with cardiac amyloidosis, a condition affecting heart function. This research targets Amyloidosis, where improved treatment options are needed.
Investor Insight
This trial focuses on a rare but serious condition, with potential to establish a new standard of care for cardiac amyloidosis patients, which could be a significant market if proven effective.
Is This Trial Right for Me?
Ask your doctor if this program is suitable for your specific condition and health status. You will attend supervised exercise sessions five days a week for five weeks, combining aerobic and strength training. Tests will be done before and about three months after the program to track your progress. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 40 participants
Interventions
- 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
Primary Outcomes
- Change in peak oxygen uptake (Baseline (Day 15))
- Change in peak oxygen uptake (Day 90)
Secondary Outcomes
- 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))
Full Eligibility Criteria
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
Trial Locations
- KRIEF, Montpellier, France
Frequently Asked Questions
What is clinical trial NCT07494942?
NCT07494942 is a Not Applicable INTERVENTIONAL study titled "Impact of a Cardiac Rehabilitation Program on Patients With Cardiac Amyloidosis." It is currently not yet recruiting and is sponsored by University Hospital, Montpellier. The trial targets enrollment of 40 participants.
What conditions does NCT07494942 study?
This trial investigates treatments for Amyloidosis. The primary condition under study is Amyloidosis.
What treatments are being tested in NCT07494942?
The interventions being studied include: 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
What does Not Applicable mean for NCT07494942?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07494942?
This trial is currently "Not Yet Recruiting." It started on 2026-04-30. The estimated completion date is 2029-01-30.
Who is sponsoring NCT07494942?
NCT07494942 is sponsored by University Hospital, Montpellier. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07494942?
The trial aims to enroll 40 participants. The trial has not yet started recruiting.
How is NCT07494942 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07494942?
The primary outcome measures are: Change in peak oxygen uptake (Baseline (Day 15)); Change in peak oxygen uptake (Day 90). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07494942 being conducted?
This trial is being conducted at 1 site, including Montpellier (France).
Where can I find official information about NCT07494942?
The official record for NCT07494942 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07494942. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07494942 testing in simple terms?
This trial tests if a structured cardiac rehabilitation program can improve exercise ability and quality of life for patients with cardiac amyloidosis. It is for adults aged 18 and older diagnosed with a specific type of cardiac amyloidosis (ATTR amyloidosis).
Why is this trial significant?
This trial addresses a gap in care by investigating if a structured cardiac rehabilitation program can improve outcomes for patients with cardiac amyloidosis, a condition affecting heart function.
What are the potential risks of participating in NCT07494942?
The main risk is potential for injury during exercise, which will be monitored closely. Some participants might experience fatigue or discomfort during the program. Side effects are generally related to exercise and will be managed by the medical team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07494942?
Ask your doctor if this program is suitable for your specific condition and health status. You will attend supervised exercise sessions five days a week for five weeks, combining aerobic and strength training. Tests will be done before and about three months after the program to track your progress. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07494942 signal from an investment perspective?
This trial focuses on a rare but serious condition, with potential to establish a new standard of care for cardiac amyloidosis patients, which could be a significant market if proven effective. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will complete a 5-week rehabilitation program and undergo tests before and after. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.