NCT06299176Enrolling by invitationPhase 1
Whole Heart Radiotherapy for End-stage Heart Failure
Phase 1 Feasibility and Safety of Whole Heart Radiotherapy for End-stage Heart Failure: First In-human Treatments
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 30 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Heart failure
- NCT number
- NCT06299176
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From 30 Apr 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous RT in the treatment field that precludes further RT
Other illness
- active connective tissue disease
Other
- interstitial pulmonary fibrosis
- Participants who are unable to be positioned in a manner where treatment can be safely delivered
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.