Radiation Therapy for Heart Failure
(ESHF-WHRT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byIan J Gerard, MD, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

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.

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.

+1 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Whole Heart Radiation TherapyExperimental Treatment1 Intervention

Whole heart radiotherapy, 5 Gy in 1 fraction