Whole Heart Radiotherapy for End-stage Heart Failure
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 1
Where in Canada
- McGill University Health CentreMontreal, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Trial code
- NCT06299176
- Record updated
- 14 May 2025
- Original description
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.Read full original descriptionShow less
Phase 1 Feasibility and Safety of Whole Heart Radiotherapy for End-stage Heart Failure: First In-human Treatments
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.
Inclusion: age ≥ 18; End-stage heart failure with NYHA class 3 or 4,; LVEF ≤ 30%; NT-Pro-BNP ≥ 1500 pg/mL; on maximum medical therapy with progressive symptoms/disease as defined by their primary cardiologist and ineligible for advanced therapies including left ventricular assist devices and heart transplant.
Exclusion: previous RT in the treatment field that precludes further RT; active connective tissue disease; interstitial pulmonary fibrosis; Participants who are unable to be positioned in a manner where treatment can be safely delivered.