Actively Recruiting
Cardiac RadiothErapy For hEart faiLure
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-01
40
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a single low dose of whole heart external beam radiotherapy (EBRT) for patients with advanced refractory heart failure (HF). The study aims to explore whether a 5 Gy dose to the whole heart can improve heart function, specifically the left ventricular ejection fraction (LVEF), by a clinically relevant 5%. The research also looks at safety, survival, hospital admissions, quality of life, and other heart function markers in people with ischemic or dilated cardiomyopathy. Participants will receive a one-time radiation treatment of 5 Gray to the whole heart using photon energies of 6 Megavoltage with advanced techniques like intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). This treatment can be done as an inpatient or outpatient procedure. The study follows patients over time to assess changes and effects of this treatment on heart function and overall health. During the study, researchers will measure heart function changes at baseline, 6 weeks, 12 weeks, and 6 months after treatment. They will monitor acute and late toxicity, mortality, hospitalizations related to heart failure, quality of life using SF-36 and MLWHF questionnaires, and several blood markers including NT-proBNP, troponin, and C-reactive protein. The study will last up to 6 months after treatment to observe these outcomes and safety aspects.
CONDITIONS
Brief Title
Cardiac RadiothErapy For hEart faiLure
Who Can Participate
Eligibility Criteria
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
- Ischemic or dilated cardiomyopathy
- Left ventricular ejection fraction (LVEF) 35% or less at baseline
- Ability to give written informed consent and willingness to return for follow-up
You will not qualify if you...
- Eligible or being considered for heart transplantation
- Pregnancy or breastfeeding
- Previous radiotherapy involving the heart
- Any condition considered a contraindication by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive a single fraction of 5 Gray whole heart external beam radiotherapy as an inpatient or outpatient procedure.
1 visit (in-person)
Duration - 6 months
Participants are monitored for changes in heart function, toxicity, and quality of life after treatment.
Visits at baseline, 6 weeks, 12 weeks, and 6 months
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
P
Patrick Berkovic, MD PhD
B
Bert Vandenberk, MD PhD
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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