Cardiac RadiothErapy For hEart faiLure

NCT ID: NCT06661876

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-06-30

Brief Summary

Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).

Objective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.

Main study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).

Conditions

Heart Failure; Non-ischemic Cardiomyopathy; Ischemic Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5Gy whole heart radiotherapy

Group Type: EXPERIMENTAL

5 Gray Whole Heart external beam radiotherapy

Intervention Type: RADIATION

EBRT will be delivered with photon energies restricted to 6 Megavoltage (MV) using intensity modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT). Patients will be treated with a single fraction treatment up to a dose of 5Gy prescribed to the 95% PTV-encompassing isodose line (PTVD95% ≥5Gy). The near-maximum dose is limited to 5.35Gy (PTV D2% ≤ 5.35Gy). The treatment can be performed both as an inpatient or outpatient procedure.

Interventions

5 Gray Whole Heart external beam radiotherapy

EBRT will be delivered with photon energies restricted to 6 Megavoltage (MV) using intensity modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT). Patients will be treated with a single fraction treatment up to a dose of 5Gy prescribed to the 95% PTV-encompassing isodose line (PTVD95% ≥5Gy). The near-maximum dose is limited to 5.35Gy (PTV D2% ≤ 5.35Gy). The treatment can be performed both as an inpatient or outpatient procedure.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patient ≥ 18 years
• Advanced refractory HF NYHA class II, III or IV
• Stable HF for the last 6 months with maximal guideline-directed HF therapy
• Ischemic or dilated cardiomyopathy
• LVEF at baseline ≤ 35%
• Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria

• Eligible or in consideration for heart transplantation
• Pregnancy or breastfeeding
• Previous radiotherapy with cardiac involvement
• Any condition that is deemed a contraindication in the judgment of the investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Patrick Berkovic, MD PhD

Role: CONTACT

patrick.berkovic@uzleuven.be

+32 16 34 51 15

Bert Vandenberk, MD PhD

Role: CONTACT

bert.vandenberk@uzleuven.be

+32 16 33 86 86

Facility Contacts

Patrick Berkovic, MD PhD

Role: primary

patrick.berkovic@uzleuven.be

+32 16 34 51 15

Other Identifiers

S69569

Identifier Type: -

Identifier Source: org_study_id