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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific type of radiation therapy, called Whole Heart Radiation Therapy, can aid individuals with severe heart failure, where the heart struggles to pump blood effectively. The goal is to determine if this treatment can improve heart function and reduce symptoms such as frequent hospital visits and irregular heartbeats. It targets individuals with very advanced heart failure who have not found relief with current treatments. Participants should have been diagnosed with end-stage heart failure and experience significant daily symptoms that other therapies cannot manage. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that whole heart radiation therapy is safe for end-stage heart failure?

Research has shown that whole heart radiation therapy can be relatively safe. Studies have found that this treatment may improve heart function in unhealthy hearts. However, radiation therapy carries risks. Some reports mention side effects, such as changes in heart rhythm and heart disease after treatment.

This therapy is still in the early stages of testing for heart failure. Early trials aim to determine its safety for people. As it hasn't been tested on many individuals yet, some risks remain unknown. Prospective participants should discuss potential risks and benefits with their doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Radiation therapy for heart failure is unique because it explores a completely new approach compared to the usual treatments like medication, lifestyle changes, and surgical interventions. Most treatments for heart failure focus on improving the heart's pumping ability or managing symptoms, but this therapy uses targeted radiation to potentially alter heart tissues at a cellular level. Researchers are excited about this treatment because it offers the possibility of addressing heart failure through a non-invasive method that could complement existing therapies, potentially leading to quicker relief and improved heart function.

What evidence suggests that whole heart radiation therapy might be an effective treatment for heart failure?

Research has shown that whole heart radiation therapy, which participants in this trial will receive, might improve heart function in people with severe heart failure. Early findings suggest this treatment can enhance the heart's ability to pump blood. It may also reduce blood markers associated with heart failure and inflammation, such as BNP and CRP. Additionally, early studies indicate that the therapy could have manageable side effects. While more research is needed, these initial results offer promise for those with limited treatment options. ^{1 2 6 7 8}

Who Is on the Research Team?

Tarek Hijal, MD

Principal Investigator

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

Ian J Gerard, MD, PhD

Principal Investigator

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

Martin L Bernier, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

My heart's pumping ability is significantly reduced.

I am 65 years old or older.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06299176

NCT06299176 | Whole Heart Radiotherapy for End-stage ... The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12574367/

Rationale and protocol of the CREFEL trial: a single-centre ... Preliminary data suggest that a single fraction low-dose whole-heart external beam radiotherapy (EBRT) may improve cardiac function by ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.021686

Radiation‐Induced Cardiovascular Disease: Review of an ... Abnormal heart rate recovery times after exercise has been found in 32% of patients having previously undergone radiation therapy compared with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660733/

Dose-volume predictors of cardiac adverse events after high ... Despite evidence from clinical trials showing that higher RT doses are associated with poorer survival outcomes due to these cardiac effects, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07037524

NCT07037524 | Low Dose Radiotherapy for Heart Failure The primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554453/

Radiation-Induced Cardiac Toxicity - StatPearls - NCBI - NIH Side effects of therapeutic radiation to the heart and coronary vessels include pericarditis, coronary artery disease (CAD), arrhythmias, cardiomyopathy, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666087321001587

Past, Present, and Future of Radiation-Induced Cardiotoxicity In this review, we provide an overview of the evolution of radiotherapy techniques in thoracic cancers and associated reductions in cardiac risk.

8. redjournal.org redjournal.org/article/S0360-3016(22)00419-9/fulltext

Beyond Mean Heart Dose: Cardiac Metrics for the Modern ... At a median follow-up of 48 months, they found a 9.6% risk of any cardiac events, with increasing mean and maximum doses to both the LAD and the whole heart ...