Cardiac Rehabilitation for Cardiac Amyloidosis

(CAPACITY Trial)

Overseen By Dana B Amaro, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: NYHA Class IV, Pulmonary disease, Gait instability, 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: 38

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable treatment for their cardiac amyloidosis or under active surveillance, which suggests you may continue your current medications.

What data supports the effectiveness of the treatment Cardiac Rehabilitation for Cardiac Amyloidosis?

Cardiac rehabilitation has been shown to improve heart function and overall well-being in patients with heart conditions, such as after a heart attack, by including exercise, diet changes, and stress management. These components can help improve symptoms and quality of life, which may also benefit patients with cardiac amyloidosis. ^{1 2 3 4 5}

Is cardiac rehabilitation safe for humans?

Exercise-based cardiac rehabilitation is generally safe and well-tolerated in humans, including those with heart disease and cancer. It has been shown to improve fitness and reduce cardiovascular risks, with no significant safety concerns reported in the studies reviewed. ^{6 7 8 9 10}

How is the Cardiac Rehabilitation treatment for Cardiac Amyloidosis different from other treatments?

Cardiac Rehabilitation for Cardiac Amyloidosis is unique because it combines structured exercise, risk factor management, psychological support, and nutrition counseling to improve heart health and overall well-being, unlike traditional treatments that may not address these aspects comprehensively. This approach is particularly beneficial for patients with cancer-related heart issues, as it helps counteract the negative effects of cancer therapies on the heart. ^{6 7 9 11 12}

Research Team

Jai Singh, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

The CAPACITY study is for adults over 18 with mild to moderate heart failure who can exercise and commit to a cardiac rehab program. They should be on stable treatment or monitored for cardiac amyloidosis, have a life expectancy of at least 6 months, and be able to attend thrice-weekly sessions.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities

Participant must be able and willing to follow the cardiac rehabilitation activities

My heart condition is being actively monitored or treated without changes.

Exclusion Criteria

I have trouble walking or have fallen before.

Inability to provide informed consent

I have severe heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing

1 week

1 visit (in-person)

Treatment

Supervised cardiac rehabilitation program including planned 3 one-hour sessions a week for a total of 12 weeks

12 weeks

36 visits (in-person)

Post-Intervention Testing

Post-intervention 6-minute walk test and CPET test performed within 2 weeks of completion of the 12-week program

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cardiac Rehabilitation

Trial Overview This trial tests the benefits of a structured exercise program (cardiac rehabilitation) in patients with heart failure who still have normal heart pumping function. It aims to see if their fitness and quality of life improve with regular supervised exercise.

Participant Groups

Group I: cardiac rehabilitation group Experimental Treatment 1 Intervention

Intervention group will have baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing followed by supervised cardiac rehabilitation program including planned 3 one hour sessions a week for a total of 12 weeks (planned 36 sessions). A post intervention 6-minute walk test and CPET test will be performed within 2 weeks of completion of the 12 week program.

Group II: control group - no intervention Active Control 1 Intervention

Control Group will have baseline 6-minute walk test and CPET testing followed by a repeat 6-minute walk test and CPET test in 12-14 weeks

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?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Cardiac rehabilitation, which includes smoking cessation and dietary changes like the Mediterranean diet, can significantly reduce cardiac events and improve overall health outcomes, including hypertension and cancer risk.

Exercise training programs within cardiac rehabilitation enhance functional capacity and symptoms in heart failure patients, highlighting the importance of these multifactorial interventions in post-cardiac event management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: where are we going? Gohlke, H., Gohlke-Bärwolf, C.[2013]

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]

In a study of 1399 patients undergoing cardiac rehabilitation programs, 93% showed improvement in functional capacity, with an average increase of 1.45 METs, indicating the effectiveness of these programs in enhancing heart health.

Patients aged 45-65 and those over 65, as well as those who had coronary artery bypass graft surgery, experienced greater improvements in functional capacity, suggesting that age and type of cardiac event may influence rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Predictors of changes in functional capacity on a cardiac rehabilitation program]. Branco, CF., Viamonte, S., Matos, C., et al.[2018]

A study involving 49 patients revealed that many did not complete their cardiac rehabilitation (CR) programs due to other health issues, lack of motivation, and domestic responsibilities, particularly among women and ethnic minority groups.

Despite not fully adhering to the CR programs, many patients reported making positive lifestyle changes, indicating that even partial participation can be beneficial and highlighting the need for tailored CR programs that consider individual circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'DNA' may not mean 'did not participate': a qualitative study of reasons for non-adherence at home- and centre-based cardiac rehabilitation. Jones, M., Jolly, K., Raftery, J., et al.[2021]

Cardiac rehabilitation, particularly exercise-based programs, has been shown to improve outcomes for patients who have experienced a myocardial infarction, enhancing functional capacity, psychosocial well-being, and health knowledge.

These rehabilitation programs are generally safe, especially when monitored with telemetry, and the review also highlights the potential benefits for patients beyond those with a history of myocardial infarction, including home-based rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. Greenland, P., Chu, JS.[2019]

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]

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, which includes exercise training and potentially other interventions, is effective for patients with coronary heart disease, leading to significant reductions in all-cause and cardiac mortality, nonfatal reinfarction, and hospitalization rates, based on a review of 71 trials involving 13,824 patients.

Despite its effectiveness, certain groups such as the elderly, women, and those with comorbidities are underrepresented in clinical trials, highlighting the need for broader inclusion in future research and the promotion of cardiac rehabilitation by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Oldridge, N.[2022]

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]

Among 442 patients with cardiovascular disease (CVD) and cancer, those who completed a 12-week exercise-based cardiac rehabilitation (CR) program had a significantly higher survival rate (80.1%) compared to those who did not complete the program (63%).

Improvements in cardiorespiratory fitness (CRF) were observed in patients who completed the CR program, but these improvements did not correlate with additional survival benefits, indicating that completing the program itself is crucial for enhancing survival among cancer patients with CVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer and cardiovascular disease: The impact of cardiac rehabilitation and cardiorespiratory fitness on survival. Williamson, T., Moran, C., Chirico, D., et al.[2022]

Cancer patients, especially those with early-stage disease, face a higher risk of cardiovascular disease due to both cancer treatments and lifestyle factors, highlighting the need for effective risk mitigation strategies.

The American Heart Association advocates for a multimodal approach, specifically cardiac rehabilitation, to support cancer patients by providing structured exercise and addressing unique cardiac risks associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Gilchrist, SC., Barac, A., Ades, PA., et al.[2020]

The field of cardio-oncology is emerging to address the cardiovascular health impacts of cancer treatments, which can have harmful effects on major organ systems, particularly the heart.

There is a need for better integration of cardio-oncology rehabilitation with overall cancer rehabilitation to support patients' health throughout their cancer journey, as current guidelines do not clearly define how to navigate this integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-oncology and Cancer Rehabilitation: Is an Integrated Approach Possible? Pituskin, E., Foulkes, SJ., Cox-Kennett, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: where are we going? [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]

3. Portugal pubmed.ncbi.nlm.nih.gov

[Predictors of changes in functional capacity on a cardiac rehabilitation program]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

'DNA' may not mean 'did not participate': a qualitative study of reasons for non-adherence at home- and centre-based cardiac rehabilitation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation-Present and Future Perspectives. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer and cardiovascular disease: The impact of cardiac rehabilitation and cardiorespiratory fitness on survival. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Cardio-oncology and Cancer Rehabilitation: Is an Integrated Approach Possible? [2023]