Clinical Trial

Whole Heart Radiotherapy for End-stage Heart Failure

Study acronym: ESHF-WHRT
Enrolling by Invitation Phase 1
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Record status
This record was last updated May 14, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-01; most recent amendment 2025-05-09.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-03-15
Trial Details
NCT Number NCT06299176
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions Heart Failure NYHA Class III, Heart Failure NYHA Class IV, End-stage Heart Failure, Heart Failure With Reduced Ejection Fraction
Enrollment 6 participants
Start Date 2025-04-30
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-14