Cardiac RadiothErapy For hEart faiLure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
5 Gray Whole Heart external beam radiotherapy
RadiationEBRT will be delivered with photon energies restricted to 6 Megavoltage (MV) using intensity modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT). Patients will be treated with a single fraction treatment up to a dose of 5Gy prescribed to the 95% PTV-encompassing isodose line (PTVD95% ≥5Gy). The near-maximum dose is limited to 5.35Gy (PTV D2% ≤ 5.35Gy). The treatment can be performed both as an inpatient or outpatient procedure.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: 5Gy whole heart radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in left ventricular ejection fraction
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.
Time frame
Baseline, week 6, week 12, and 6 monthsSecondary outcomes
1
Acute toxicity
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.
Time frame
toxicity occurring within 30 days after the radiation treatment.2
All-cause mortality
Death from any cause within 6 months after treatment. The Kaplan-Meier method will be used to estimate overall survival (OS).
Time frame
6 months after the radiation treatment3
Heart failure hospitalisation
The number and length of hospitalization related to HF after treatment and within 6 months after treatment. HF-related admissions are defined as a hospital admission lasting for more than 24 h, with signs or symptoms of congestion necessitating an increase of the dose of loop diuretics.
Time frame
Within 6 months after the radiation treatment4
Late toxicity
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.
Time frame
30 days to 6 months after the radiation treatmentSponsors and contacts
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Source ClinicalTrials.gov