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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRennes University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Minimum age: 18 years

Ischaemic or non-ischaemic cardiomyopathies

Optimal medical treatment

LVEF ≤ 40%

Disqualifiers

Pregnancy or breastfeeding

History of thoracic radiotherapy

History of aortic and mitral valve surgery

Contraindications to MRI (claustrophobia, presence of metallic foreign bodies)

Trial design

Treatments tested in this trial

  • Low-dose cardiac radiation therapy (5 Gy)

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators