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Whole Heart Radiotherapy for End-stage Heart Failure

NCT06299176 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV
  • End-stage Heart Failure
  • Heart Failure With Reduced Ejection Fraction

Interventions

OTHER

Whole Heart Radiation Therapy

Radiation to the whole heart in one treatment with a prescribed dose of 5 Gy.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Ian J Gerard, MD, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Tarek Hijal, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Martin L Bernier, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299176 on ClinicalTrials.gov