Radiation Therapy for Heart Failure

(ESHF-WHRT Trial)

Overseen By Joanne Alfieri, MD

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Previous RT, Connective tissue disease, Pulmonary fibrosis, others

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

Compensation: Varies

Number of Visits: 7

6 Participants Needed

Trial Summary

What is the purpose of this trial?

End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that participants should be on maximum medical therapy, which suggests you may need to continue your current treatments.

What data supports the effectiveness of the treatment Whole Heart Radiation Therapy for heart failure?

The research suggests that radiation therapy, when used for breast cancer, has improved survival rates by reducing tumor cells, but it also highlights the importance of minimizing heart exposure to avoid long-term heart issues. This indicates that while radiation can be effective in treating certain conditions, careful planning is needed to protect the heart. ^{1 2 3 4 5}

Is radiation therapy generally safe for the heart?

Radiation therapy can cause heart problems, such as heart dysfunction and damage, especially when the heart is exposed during treatment for cancers like breast cancer. These heart issues can include changes in heart function and structure, and they may not show symptoms right away but can lead to serious conditions if not monitored and managed. ^{6 7 8 9 10}

How does the treatment Whole Heart Radiation Therapy differ from other treatments for heart failure?

Whole Heart Radiation Therapy is unique because it uses radiation, typically used for cancer treatment, to target the heart in heart failure patients. This approach is novel as it aims to manage heart failure by potentially reducing harmful heart tissue changes, unlike traditional heart failure treatments that focus on medications or lifestyle changes. ^{6 11 12 13 14}

Research Team

Ian J Gerard, MD, PhD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Tarek Hijal, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

This trial is for individuals at least 65 years old with end-stage heart failure (NYHA class 3-4) and a left ventricular ejection fraction (LVEF) of 30% or less. Participants should be on maximum medical therapy but still experiencing worsening symptoms as determined by their cardiologist.

Inclusion Criteria

I am 65 years old or older.

My heart failure is severe, making daily tasks very difficult.

My heart's pumping ability is significantly reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 5 Gy whole heart radiotherapy in 1 fraction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual) at 6 weeks, 12 weeks, and 24 weeks

Treatment Details

Interventions

• Whole Heart Radiation Therapy

Trial Overview The study is testing the safety and feasibility of whole heart radiotherapy, delivering a dose of 5 Gy, in six patients with severe heart failure who have limited treatment options. The goal is to see if this can improve heart function and reduce markers indicating heart failure and inflammation.

Participant Groups

Group I: Whole Heart Radiation Therapy Experimental Treatment 1 Intervention

Whole heart radiotherapy, 5 Gy in 1 fraction

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

References

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

Myocardial perfusion changes in patients irradiated for left-sided breast cancer and correlation with coronary artery distribution. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effective heart-sparing whole lung irradiation using volumetric modulated arc therapy: a case report. [2020]

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

Meta-Analysis of Association Between Mediastinal Radiotherapy and Long-Term Heart Failure. [2017]

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

The role of radiation therapy for primary breast cancer. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Novel approaches using radiation therapies. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Differences in radiation-induced heart dysfunction in male versus female rats. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Epac contributes to cardiac hypertrophy and amyloidosis induced by radiotherapy but not fibrosis. [2018]

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

The incidence and functional consequences of RT-associated cardiac perfusion defects. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Cardiovascular sequelae of radiation therapy. [2021]

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

Cardiac Magnetic Resonance for Early Detection of Radiation Therapy-Induced Cardiotoxicity in a Small Animal Model. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of proton therapy on cardiotoxicity following radiation treatment. [2021]

12. Turkey pubmed.ncbi.nlm.nih.gov

Severe valvular toxicity and pericarditis early after radiation therapy in a patient treated for Hodgkin's lymphoma. [2010]

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

Serial Measurement of Global Longitudinal Strain Among Women With Breast Cancer Treated With Proton Radiation Therapy: A Prospective Trial for 70 Patients. [2023]

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

Cardiac Function Modifies the Impact of Heart Base Dose on Survival: A Voxel-Wise Analysis of Patients With Lung Cancer From the PET-Plan Trial. [2023]