RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

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 ventricular myocardium (both ventricles) 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.

Study 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 LVEF 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.

Eligibility

Primary outcome measure(s)

• Medium-term left ventricular function — 6 months [± 15 days] - complete-case analysis
  Difference between the baseline value and the 6-month value of LVEF as assessed by cardiac MRI. Mean difference with 95% CI. Paired plot (spaghetti plot) of baseline values versus 6-month values.

Trial sites (1)

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