RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure: an Exploratory Single-Arm Study

RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure: an Exploratory Single-Arm Study

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.

Inclusion Criteria:

1. Minimum age: 18 years
2. Ischaemic or non-ischaemic cardiomyopathies
3. Optimal medical treatment
4. LVEF ≤ 40%
5. NYHA class II or III
6. Life expectancy > 6 months
7. At least one hospital admission for heart failure within the 6 months prior to inclusion, or NT-pro BNP ≥ 1,000 pg/mL
8. Contraindications to heart transplantation and left ventricular or biventricular assist devices
9. Having given their free and informed written consent
10. Covered by a health insurance scheme

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. History of thoracic radiotherapy
3. History of aortic and mitral valve surgery
4. Contraindications to MRI (claustrophobia, presence of metallic foreign bodies)
5. Participation in another ongoing interventional study
6. Adults subject to legal protection measures (judicial protection, guardianship, curatorship), deprived of their liberty, or unable to give informed consent.