Cardiac RadiothErapy For hEart faiLure

NCT06661876 | Recruiting

• 1 other identifier: S69569
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

external beam radiotherapy; heart failure

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction

  The hypothesis, based on recent preclinical and clinical data, is that 5Gy whole heart radiotherapy in advanced refractory HF patients can improve the LVEF and increase QOL with a low to very low toxicity profile. The efficacy will be defined as an improvement of at least 5% of the LVEF over a period of 6 months.

  Baseline, week 6, week 12, and 6 months

Secondary Outcomes (11)

• Acute toxicity

  toxicity occurring within 30 days after the radiation treatment.

• All-cause mortality

  6 months after the radiation treatment

• Heart failure hospitalisation

  Within 6 months after the radiation treatment

• Late toxicity

  30 days to 6 months after the radiation treatment

• Quality of life - SF-36

  Baseline, 6 weeks, 12 weeks, and 6 months

Study Arms (1)

5Gy whole heart radiotherapy

EXPERIMENTAL

Radiation: 5 Gray Whole Heart external beam radiotherapy

Interventions

5 Gray Whole Heart external beam radiotherapy 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.

5Gy whole heart radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Patrick Berkovic, MD PhD

CONTACT

+32 16 34 51 15; patrick.berkovic@uzleuven.be

Bert Vandenberk, MD PhD

CONTACT

+32 16 33 86 86; bert.vandenberk@uzleuven.be

Study Design

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

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 28, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the main results, for at least 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. Access will be granted upon approval of a data use agreement.

Locations

BE (1)