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

NCT07770230 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-18

No results posted yet for this 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 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.

Conditions

  • Advanced or End-stage Heart Failure

Interventions

RADIATION

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.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-03-31
Completion
2029-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770230 on ClinicalTrials.gov