Using radiotherapy to treat advanced heart failure
Cardiac RadiothErapy For hEart faiLure
This study is testing if a single low dose of radiation therapy can help people with advanced heart failure feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06661876 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a single low dose of whole heart external beam radiotherapy (EBRT) on patients with advanced refractory heart failure. The treatment involves administering 5 Gray of EBRT to assess its efficacy in improving left ventricular ejection fraction (LVEF) by at least 5%. The study will also evaluate safety, overall survival, hospital admissions, late toxicity, quality of life, and other heart function indicators. Participants must have stable heart failure and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced refractory heart failure and a left ventricular ejection fraction of 35% or less.
Not a fit: Patients who are eligible for heart transplantation or have had previous radiotherapy involving the heart may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced heart failure who have not responded to conventional therapies.
How similar studies have performed: Preliminary data suggests potential benefits, but this approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Patrick Berkovic, MD PhD
- Email: patrick.berkovic@uzleuven.be
- Phone: +32 16 34 51 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.