Cardiac RadiothErapy For hEart faiLure
Recruiting · NCT06661876 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
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
Where it is running
1 location listed.
- UZ Leuven - Leuven, Belgium