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Recruiting NCT06661876

Cardiac RadiothErapy For hEart faiLure

No phase Interventional Heart Failure Non-ischemic Cardiomyopathy Ischemic Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5 Gray Whole Heart external beam radiotherapy.
Who it may be relevant to
Registry conditions: Heart Failure, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Radiation 5 Gray Whole Heart external beam radiotherapy
    EBRT 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.

Primary outcome measures

  • Change in left ventricular ejection fraction [Time frame: Baseline, week 6, week 12, and 6 months]
Secondary outcome measures (11)
  • Acute toxicity [Time frame: toxicity occurring within 30 days after the radiation treatment.]
  • All-cause mortality [Time frame: 6 months after the radiation treatment]
  • Heart failure hospitalisation [Time frame: Within 6 months after the radiation treatment]
  • Late toxicity [Time frame: 30 days to 6 months after the radiation treatment]
  • Quality of life - SF-36 [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]
  • Quality of life - MLWHF [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]
  • NT-proBNP levels [Time frame: Baseline, week 6, week 12, and 6 months]
  • High-sensitive troponin levels [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]
  • High-sensitivity C-reactive protein [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]
  • Left ventricular volumes [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]
  • Ventricular arrhythmia burden [Time frame: Baseline, 6 weeks, 12 weeks, and 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06661876 · S69569

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗