Cardiac RadiothErapy For hEart faiLure
- Conditions
- Heart FailureNon-ischemic CardiomyopathyIschemic Cardiomyopathy
- Registration Number
- NCT06661876
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in left ventricular ejection fraction Baseline, week 6, week 12, and 6 months The hypothesis, based on recent preclinical and clinical data, is that 5Gy whole heart radiotherapy in advanced refractory HF patients can improve the LVEF and increase QOL with a low to very low toxicity profile. The efficacy will be defined as an improvement of at least 5% of the LVEF over a period of 6 months.
- Secondary Outcome Measures
Name Time Method Acute toxicity toxicity occurring within 30 days after the radiation treatment. The tolerable acute toxicity will be assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) (U.S. Department of Health and Human Services 2017). It is defined as toxicity occurring within 30 days after the radiation treatment.
Late toxicity 30 days to 6 months after the radiation treatment Late toxicity is defined as toxicity occurring after at least 30 days to 6 months after the radiation treatment and will be assessed by the CTCAE v5.0.
Quality of life - SF-36 Baseline, 6 weeks, 12 weeks, and 6 months Health related quality-of-life (QOL) will be measured based on the SF-36. The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.
Quality of life - MLWHF Baseline, 6 weeks, 12 weeks, and 6 months Health related quality-of-life (QOL) will be measured based on the Minnesota Living with Heart Failure (MLWHF) questionnaire. The MLWHFis a valid and reliable instrument consisting of 21 items for measuring QOL in patients with HF. It covers various domains including physical, emotional, social, and mental aspects of living with heart failure. Each item is scored on a scale (usually 0 to 5 or 0 to 6), with higher scores indicating a greater impact.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium