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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cardiac rehabilitation can enhance well-being and fitness in individuals with heart failure due to cardiac amyloidosis. Participants will either join a supervised exercise program or be part of a control group without exercise intervention, allowing for a comparison of effects. It suits individuals who can exercise, have manageable heart failure symptoms, and are stable with their current treatment for cardiac amyloidosis. As an unphased trial, this study provides a unique opportunity to contribute to understanding how exercise can improve quality of life for those with cardiac amyloidosis.

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 prior data suggests that cardiac rehabilitation is safe for patients with cardiac amyloidosis?

Research has shown that exercise-based cardiac rehabilitation is generally safe and well-tolerated, even for individuals with heart conditions. Studies indicate that this type of program can enhance fitness and quality of life. One study found that 70% of patients with cardiac amyloidosis completed the rehabilitation program without major issues. Although some participants couldn't finish for various reasons, the treatment itself didn't cause significant side effects. Overall, this suggests that cardiac rehabilitation is a safe option for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cardiac rehabilitation for cardiac amyloidosis because it offers a non-invasive approach that focuses on improving patients' physical fitness and overall heart health through structured exercise. Unlike traditional treatments, which often involve medications to manage symptoms or slow disease progression, cardiac rehabilitation emphasizes a hands-on, active strategy that may enhance quality of life and functional capacity. This method could provide a complementary option to existing drug therapies, potentially offering benefits like increased exercise tolerance and reduced cardiac strain without the side effects associated with medications.

What evidence suggests that cardiac rehabilitation is effective for cardiac amyloidosis?

Research has shown that cardiac rehabilitation, which participants in this trial may receive, can benefit patients with cardiac amyloidosis. Specifically, those who completed cardiac rehab demonstrated better heart and lung fitness and experienced less fatigue compared to those who did not. Exercise training for patients with heart failure and preserved ejection fraction (HFpEF) is also associated with improved fitness and quality of life. Studies indicate a 50% improvement in exercise capacity and a 44% improvement in walking distance over six minutes. Overall, these findings suggest that cardiac rehabilitation may enhance physical fitness and reduce fatigue for individuals with cardiac amyloidosis. ^{1 2 3 4 6}

Who Is on the Research Team?

Jai Singh, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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, 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]

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 (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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12525585/

Functional Capacity Evaluation and Rehabilitation ... Historically, untreated AL cardiac amyloidosis had a median survival of only ~6–12 months due to its rapid progression [30]. ATTR amyloidosis ...

2. withpower.com withpower.com/trial/phase-amyloidosis-9-2023-a292c

Cardiac Rehabilitation for Cardiac Amyloidosis Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06096675

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) ... Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness ...

4. researchgate.net researchgate.net/publication/371880629_Feasibility_of_Cardiac_Exercise_Rehabilitation_in_Patients_with_Cardiac_Amyloidosis

(PDF) Feasibility of Cardiac Exercise Rehabilitation in ... Results: Overall, 27 cardiac amyloidosis patients were recruited. Cardiac exercise rehabilitation was feasible in 19 (70%) and not feasible in 8 (30%). Of the ...

5. atriumhealth.org atriumhealth.org/medical-services/specialty-care/heart-care/sanger-outcomes-and-innovation-2023/cardiac-rehabilitation

Cardiac Rehabilitation: 2023 Outcomes and Innovation 50% Improvement in Patient Max METS (Metabolic Equivalent) Internal Data, YTD September 2023 · 44% Improvement in Patient 6 MWT Distance Internal Data, YTD ...

6. jacc.org jacc.org/doi/10.1016/j.jaccao.2021.05.004

Two Decades of Cardiac Amyloidosis: A Danish ... Cardiac amyloidosis (CA) has been associated with a high 5-year mortality of 44%-65% after diagnosis (1). Screening studies show higher ...