RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRennes University Hospital
About this trial
The RADIATE-HF study is a prospective, interventional, single-center, open-label, non-randomized study conducted at the Rennes University Hospital.
The goal of this proof-of-concept trial is to demonstrate that low-dose cardiac radiation therapy (5 Gy) improves left ventricular function by more than 5% in the medium term in patients with advanced or end-stage heart failure.
The primary endpoint is the difference between the baseline value and the 6-month value of the LVEF as assessed by cardiac MRI.
The study includes a single group of 20 patients receiving the intervention (cardiac radiation).
The study is being conducted at a single investigator site.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Minimum age: 18 years
Ischaemic or non-ischaemic cardiomyopathies
Optimal medical treatment
LVEF ≤ 40%
Disqualifiers
Pregnancy or breastfeeding
History of thoracic radiotherapy
History of aortic and mitral valve surgery
Contraindications to MRI (claustrophobia, presence of metallic foreign bodies)
Trial design
Design model
Single group
Treatments tested in this trial
Low-dose cardiac radiation therapy (5 Gy)
RadiationParticipants included in the RADIATE-HF study will receive a single-fraction cardiac radiotherapy treatment of 5 Gy, delivered by a linear accelerator (LINAC). This strategy aims to expose the ventricular myocardium (both ventricles) to a low, uniform dose, based on preclinical findings suggesting an anti-fibrotic and anti-remodelling effect. The procedure comprises three successive phases: 1. Pre-treatment assessments, 2. Planning and delivery of radiotherapy, 3. Post-treatment assessments.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Low-dose cardiac radiation therapy (5 Gy)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Medium-term left ventricular function
Difference between the baseline value and the 6-month value of LVEF as assessed by cardiac MRI. Mean difference with 95% CI. Paired plot (spaghetti plot) of baseline values versus 6-month values.
Time frame
6 months [± 15 days] - complete-case analysisSecondary outcomes
1
Ventricular dimensions and function, and the response in terms of myocardial structure and function on MRI
Difference between baseline and 6-month values, as assessed by cardiac MRI, of: * right ventricular ejection fraction * left ventricular end-diastolic volume * right ventricular end-diastolic volume * left ventricular end-systolic volume * right ventricular end-systolic volume * late enhancement * T1 and T2 mapping * extracellular volume. Difference in mean with 95% CI; paired plot (spaghetti plot) comparing baseline values with those at 6 months.
Time frame
6 months [± 15 days] - complete-case analysis: as the number of patients included in the study (n = 20) is limited, no multiple imputation will be performed; all assessments will be carried out on patients with complete data.2
Ventricular dimensions and function, and the response in terms of myocardial structure and function on echocardiography
Difference between the baseline value and the value at 6 months, as assessed by echocardiography, of * the left ventricular ejection fraction * the global longitudinal strain, * myocardial work * left ventricular end-diastolic volume * left ventricular end-diastolic diameter * left ventricular end-systolic volume * cardiac output Difference in mean with 95% CI; paired plot (spaghetti plot) comparing baseline values with those at 6 months.
Time frame
6 months [± 15 days] - complete-case analysis: as the number of patients included in the study (n = 20) is limited, no multiple imputation will be performed; all assessments will be carried out on patients with complete data.3
Serious complications related to the procedure
Percentage of patients experiencing at least one serious complication (6 months) related to radiotherapy. Severity is defined according to CTCAE v6 as grade 3 toxicity requiring hospitalisation or grade 4 or 5 toxicity. Percentage with 95% CI. Adverse events will also be presented using the MedDRA 'Preferred Terms' and their severity will be assessed according to the CTCAE \[\< 3 or ≥ 3\].
Time frame
6 months [± 15 days] - safety analysis set: the safety analysis population will include all patients who received single-fraction radiotherapy, regardless of completion or compliance with the protocol.4
Hospitalisation for cardiovascular reasons
Number of patients hospitalised for cardiovascular reasons (i.e. heart failure, arrhythmias) at 6 months. Percentage with 95% CI
Time frame
6 months [± 15 days] - complete-case analysisSponsors and contacts
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Source ClinicalTrials.gov
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