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

NCT07770230 | Not Yet Recruiting

• 3 other identifiers: 35RC24_8825_01_RADIATE-HF2026-A01293-4826.02065.000506
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

advanced or end-stage heart failure; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Medium-term left ventricular function

  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.

  6 months [± 15 days] - complete-case analysis

Secondary Outcomes (8)

• Ventricular dimensions and function, and the response in terms of myocardial structure and function on MRI

  6 months [± 15 days] - complete-case analysis: as the number of patients included in the study (n = 20) is limited, no multiple imputation will be performed; all assessments will be carried out on patients with complete data.

• Ventricular dimensions and function, and the response in terms of myocardial structure and function on echocardiography

  6 months [± 15 days] - complete-case analysis: as the number of patients included in the study (n = 20) is limited, no multiple imputation will be performed; all assessments will be carried out on patients with complete data.

• Serious complications related to the procedure

  6 months [± 15 days] - safety analysis set: the safety analysis population will include all patients who received single-fraction radiotherapy, regardless of completion or compliance with the protocol.

• Hospitalisation for cardiovascular reasons

  6 months [± 15 days] - complete-case analysis

• Quality of life assessment

  6 months [± 15 days] - complete-case analysis

Study Arms (1)

Low-dose cardiac radiation therapy (5 Gy)

EXPERIMENTAL

Radiation: Low-dose cardiac radiation therapy (5 Gy)

Interventions

Low-dose cardiac radiation therapy (5 Gy) RADIATION

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.

Low-dose cardiac radiation therapy (5 Gy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age: 18 years
• Ischaemic or non-ischaemic cardiomyopathies
• Optimal medical treatment
• LVEF ≤ 40%
• NYHA class II or III
• Life expectancy \> 6 months
• Contraindications to heart transplantation and left ventricular or biventricular assist devices
• Having given their free and informed written consent
• Covered by a health insurance scheme

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, France, 35000, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Guillaume L'Official, MD

CONTACT

02 99 28 25 25; guillaume.l.official@chu-rennes.fr

Raphaël Martins, MD

CONTACT

02 99 28 25 41; raphael.martins@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low-dose cardiac radiation therapy (5 Gy)

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

FR (1)