| NCT ID | NCT06661876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06661876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06661876 currently recruiting?
Yes, NCT06661876 is actively recruiting participants. Contact the research team at patrick.berkovic@uzleuven.be for enrollment information.
Where is the NCT06661876 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06661876 clinical trial?
NCT06661876 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 40 participants.
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