Cardiac RadiothErapy For hEart faiLure (CREFEL)

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Heart Failure

Non-ischemic Cardiomyopathy

Ischemic Cardiomyopathy

Treatments

Radiation: 5 Gray Whole Heart external beam radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06661876

S69569

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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