Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06661876 | RECRUITING | Heart Failure

Cardiac RadiothErapy For hEart faiLure
Sponsor:

University hospitals 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).

Condition or disease

Heart Failure

Non-ischemic Cardiomyopathy

Ischemic Cardiomyopathy

Intervention/treatment

5 Gray Whole Heart external beam radiotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Cardiac RadiothErapy For hEart faiLure
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Cardiac RadiothErapy For hEart faiLure

Location Details

NCT06661876

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Belgium,

UZ Leuven

Leuven, Belgium, 3000