RecruitingNot ApplicableNCT06661876

Cardiac RadiothErapy For hEart faiLure

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

40 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Non-ischemic Cardiomyopathy Ischemic Cardiomyopathy

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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

Interventions

RADIATION5 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.