Cardiac Rehabilitation for Congenital Heart Failure

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Inotrope-dependence, Uncontrolled arrhythmias, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cardiac rehabilitation can benefit individuals with Fontan failure, a condition that can occur after heart surgery, by increasing daily activity and enhancing heart health and quality of life. Participants will either join a cardiac rehab program or continue with their usual care to determine which approach is more effective. The trial seeks individuals who have undergone the Fontan procedure and face challenges such as low heart function or the need for specific medications. Participants will receive a Fitbit to track daily steps and assess how rehab impacts their daily lives. As an unphased trial, this study provides a unique opportunity to contribute to understanding how cardiac rehab can improve life for those with Fontan failure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cardiac rehabilitation is safe for Fontan failure patients?

Research has shown that cardiac rehabilitation is generally safe for people with heart conditions. One study found that it lowers the risk of death and improves life quality for those with heart issues. Serious side effects rarely occur. Another study found that patients who participated in cardiac rehab became more physically active and gained a better understanding of their condition.

Although this treatment is not yet standard for everyone with congenital heart disease, early programs have demonstrated benefits such as improved health and increased physical activity. Since cardiac rehabilitation is often recommended for various heart conditions, it is considered safe and well-tolerated for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cardiac rehabilitation for congenital heart failure because it offers a personalized and flexible approach to care. Unlike traditional treatments that primarily focus on medication management and surgery, this program provides a comprehensive lifestyle intervention. It can be tailored to fit the patient's needs, offering in-person, hybrid, or virtual sessions, making it accessible regardless of location. Additionally, the use of Fitbits for daily activity tracking encourages ongoing engagement and self-monitoring, potentially enhancing long-term heart health.

What evidence suggests that cardiac rehabilitation might be an effective treatment for Fontan failure?

Research shows that cardiac rehabilitation, which participants in this trial may receive, can help people with heart conditions feel better and live healthier lives. Studies have found that it enables patients with heart failure to become more active, such as taking more daily steps. It also improves their ability to handle physical activity without getting out of breath. Additionally, cardiac rehabilitation is linked to a better quality of life and reduced frailty. Although specific data on patients with Fontan failure is limited, the positive effects observed in other heart conditions suggest it could benefit these patients as well. ^{1 3 6 7 8}

Who Is on the Research Team?

Daniel E Clark, MD, MPH

Principal Investigator

Stanford University

Jonathan N Menachem, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Fontan failure, which means they've had a specific heart surgery and have issues like low heart pump function or need chronic diuretics. It's not for those dependent on drugs to support heart contractions, uncontrolled irregular heartbeats, pregnant women, current cardiac rehab patients, or those planning another heart procedure soon.

Inclusion Criteria

I have had a Fontan procedure and suffer from heart or lung issues, or need chronic medication for fluid buildup.

Exclusion Criteria

Inability to comply with the protocol

Resting hypoxemia with baseline oxygen saturation <80%

I have had a recent Fontan procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in either cardiac rehabilitation or usual care. Cardiac rehabilitation involves 3 sessions per week for 12 weeks.

12 weeks

36 sessions (in-person, hybrid, or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of daily activity and health metrics.

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Rehabilitation

Trial Overview

The study aims to see if a special exercise and education program (cardiac rehabilitation) can help people with Fontan failure walk more steps daily and improve their exercise capacity, frailty level, and life quality compared to usual care without this program.

How Is the Trial Designed?

Group I: Cardiac rehabilitation Experimental Treatment 1 Intervention

For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.

Group II: Usual care Active Control 1 Intervention

For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.

Cardiac Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Cardiac Rehabilitation for:

• Cardiovascular disease prevention in cancer survivors
• Improvement of cardiorespiratory fitness in cancer patients

Approved in European Union as Cardio-Oncology Rehabilitation for:

• Reduction of cardiovascular risk in cancer survivors
• Management of cardiotoxicity related to cancer therapies

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Julie Fletcher Memorial Fund

Collaborator

Trials

1

Recruited

50+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Pete Huttlinger Memorial Fund

Collaborator

Trials

1

Recruited

50+

Adult Congenital Heart Association

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

As the number of cancer survivors increases, so does the risk of cardiovascular disease (CVD) among them, highlighting the need for integrated care in cancer treatment.

Cardio-oncology rehabilitation (CORE) is a new approach designed to reduce CVD risk and enhance fitness in cancer survivors through tailored exercise and cardiac rehabilitation, addressing the emerging issue of cancer treatment-related cardiovascular disease (CTRCD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. Sase, K., Kida, K., Furukawa, Y.[2021]

Cardiac rehabilitation in Germany has shown a significant reduction in total mortality, myocardial infarction, and hospitalization rates over 1-2 years in 10,758 patients following myocardial infarction and bypass surgery, highlighting its efficacy as a secondary prevention strategy.

The program is recommended for various heart conditions, including congestive heart failure and post-surgical recovery, and future evaluations should focus on personalized interventions for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular rehabilitation]. Schwaab, B.[2021]

Acute-phase cardiovascular rehabilitation (CR) in the ICU significantly improves in-hospital outcomes, such as walking independence (2.04 times more likely) and returning home (22% more likely) for patients with cardiovascular disease, based on a study of 1,948 patients.

Patients who received ICU-CR experienced lower rates of all-cause readmission and cardiovascular events over a 5-year period, indicating that ICU-CR not only benefits immediate recovery but also enhances long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and Outcomes of Early Rehabilitation in the Intensive Care Unit for Patients With Cardiovascular Disease: A Cohort Study With Propensity Score-Matched Analysis. Hamazaki, N., Kamiya, K., Nozaki, K., et al.[2023]

Cardiac rehabilitation (CR) significantly reduces all-cause mortality in patients after acute coronary syndrome (ACS) and coronary bypass grafting (CABG), while improving exercise capacity and quality of life in patients with heart failure (HFrEF).

The effectiveness of CR is influenced by treatment intensity, including medical supervision and personalized exercise plans, and additional psychological interventions can help reduce depressive symptoms and improve patient motivation and behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac Rehabilitation]. Schwaab, B.[2022]

The QUALI-REHAB trial is a nationwide study involving 130 adolescents and young adults (ages 13 to 25) with congenital heart disease (CHD) to evaluate the effectiveness of a 12-week combined center and home-based cardiac rehabilitation program on improving quality of life and exercise capacity.

The primary outcome will measure changes in quality of life using the PedsQL score over 12 months, with secondary outcomes including improvements in exercise capacity (VO2max), clinical outcomes, and overall safety and acceptability of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Amedro, P., Gavotto, A., Legendre, A., et al.[2019]

Cardiac rehabilitation, which includes exercise training and various therapeutic adaptations, is crucial for patients with chronic heart failure and has been shown to improve functional capacity and reduce symptoms.

The program not only enhances physical health but also lowers cardiac morbidity and mortality by improving muscle function, endothelial health, and reducing sympathetic tone, which can help prevent arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of rehabilitation in the treatment of chronic heart insufficiency]. Iliou, MC.[2019]

Cardiac rehabilitation (CR) was found to be effective and safe for adolescents and adults with congenital heart disease (CHD), with significant improvements in exercise capacity and heart rate after participation.

Out of 36 patients referred over 4 years, 23 completed CR with no serious adverse events reported, highlighting the program's safety and the need to address barriers like accessibility and cost to improve participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation for Adults and Adolescents With Congenital Heart Disease: EXTENDING BEYOND THE TYPICAL PATIENT POPULATION. Sarno, LA., Misra, A., Siddeek, H., et al.[2021]

The rise in cancer survival rates has led to an increase in patients facing both cancer and cardiovascular diseases, highlighting the need for integrated care in cardio-oncology to manage shared risk factors and mitigate the cardiotoxic effects of cancer treatments.

The Cardio-Oncology REhabilitation (CORE) program is an exercise-based intervention designed to improve cardiovascular health in cancer patients, offering benefits such as enhanced cardiorespiratory fitness, better quality of life, and psychological support, while also addressing barriers to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. Venturini, E., Gilchrist, S., Corsi, E., et al.[2022]

Cardiac rehabilitation is now recommended for a wider range of patients, including those with congenital heart disease, those with implantable cardioverter defibrillators (ICDs), and patients with stable chronic heart failure, not just those recovering from coronary artery disease.

The rehabilitation programs, which include physical training as well as psycho-social counseling, are safe and beneficial for these patients, especially when guided by pretraining exercise tests to determine appropriate physical workloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac rehabilitation in patients with a congenital heart disease, an implantable cardioverter defibrillator or chronic heart failure]. Brügemann, J., Postema, K., van Gelder, IC., et al.[2007]

Cardiac Rehabilitation Programmes for children with congenital heart disease are underutilized, with only 16 studies reviewed from 1981 to 2010, indicating a significant gap in research and application for this population.

The studies primarily focused on aerobic and resistance training, showing no adverse events, but highlighted the need for more comprehensive outcome measures to assess the efficacy and structure of these rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric cardiac rehabilitation in congenital heart disease: a systematic review. Tikkanen, AU., Oyaga, AR., Riaño, OA., et al.[2022]

Cardiotoxicity from anti-cancer drugs is a significant concern, contributing to over 40% of cancer deaths, and is linked to mechanisms like DNA damage and oxidative stress.

Exercise training is safe and well-tolerated in cancer patients, leading to a 10-15% improvement in cardiorespiratory fitness, and may help counteract the adverse cardiovascular effects of cancer therapies, making tailored cardiac rehabilitation programs a promising option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation-Present and Future Perspectives. Elad, B., Habib, M., Caspi, O.[2022]

Cardiac rehabilitation (CR) for cancer survivors shows low-to-moderate quality in reporting and moderate-to-high risk of bias, which affects the reliability of the findings and their application in clinical practice.

Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not participate in CR, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. Fakhraei, R., Peck BKin, SS., Abdel-Qadir, H., et al.[2022]

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Core Components of Cardiac Rehabilitation Programs

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