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Whole Heart Radiotherapy for End-stage Heart Failure

Study acronym: ESHF-WHRT
StatusEnrolling by Invitation
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Primary endpoints: 2 to 1v3 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Apr 30, 2025
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 12 to 14
    • Study description expanded, about 633 words
  2. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date: Apr 1, 2024 to Apr 1, 2025
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06299176
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Heart Failure NYHA Class III, Heart Failure NYHA Class IV, End-stage Heart Failure, Heart Failure With Reduced Ejection Fraction
Related terms Heart Failure
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov