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

Plain Language Summary

Simplified for easier understanding

This study tests whether a single low dose of radiation delivered precisely to a specific area of the heart can improve heart function and symptoms in people with severe, advanced heart failure that no longer responds to medications. The radiation targets a small region believed to affect heart rhythm and function. **You may be eligible if...** - You are 18 or older with advanced heart failure (NYHA class II, III, or IV) - Your heart failure is caused by ischemic heart disease (blocked arteries) or dilated cardiomyopathy (enlarged, weakened heart) - Your heart pumps less than 35% of its blood per beat (reduced ejection fraction) - You have been on maximum tolerated guideline-based heart failure medications for at least 6 months **You may NOT be eligible if...** - You are a candidate for or are being considered for a heart transplant - You are pregnant or breastfeeding - You have had previous radiation therapy involving the heart - You have other conditions that the investigators determine are a contraindication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

UZ Leuven

Leuven, Belgium

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NCT06661876

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