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RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure: an Exploratory Single-Arm Study
Sponsor: Rennes University Hospital
Summary
The RADIATE-HF study is a prospective, interventional, single-center, open-label, non-randomized study conducted at the Rennes University Hospital. The goal of this proof-of-concept trial is to demonstrate that low-dose cardiac radiation therapy (5 Gy) improves left ventricular function by more than 5% in the medium term in patients with advanced or end-stage heart failure. The primary endpoint is the difference between the baseline value and the 6-month value of the FEVG as assessed by cardiac MRI. The study includes a single group of 20 patients receiving the intervention (cardiac radiation). The study is being conducted at a single investigator site.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-09-01
Completion Date
2029-09
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Low-dose cardiac radiation therapy (5 Gy)
Participants included in the RADIATE-HF study will receive a single-fraction cardiac radiotherapy treatment of 5 Gy, delivered by a linear accelerator (LINAC). This strategy aims to expose the entire myocardium to a low, uniform dose, based on preclinical findings suggesting an anti-fibrotic and anti-remodelling effect. The procedure comprises three successive phases: 1. Pre-treatment assessments, 2. Planning and delivery of radiotherapy, 3. Post-treatment assessments.
Locations (1)
Rennes University Hospital
Rennes, France