Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06661876

Cardiac RadiothErapy For hEart faiLure

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-01

40

Participants Needed

1

Research Sites

130 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Cardiac RadiothErapy For hEart faiLure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years or older
  • Advanced refractory heart failure NYHA class II, III, or IV
  • Stable heart failure for the last 6 months with maximal guideline-directed therapy
  • Diagnosis of ischemic or dilated cardiomyopathy
  • Left ventricular ejection fraction at baseline 35% or less
  • Ability to give written informed consent and willingness to return for follow-up
Not Eligible

You will not qualify if you...

  • Eligible or being considered for heart transplantation
  • Pregnancy or breastfeeding
  • Previous radiotherapy involving the heart
  • Any condition deemed a contraindication by the investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

P

Patrick Berkovic, MD PhD

CONTACT

B

Bert Vandenberk, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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