An interventional study of Low-dose cardiac radiation therapy (5 Gy) in Heart Failure, sponsored by Rennes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 20 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: Low-dose cardiac radiation therapy (5 Gy)
Participants 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.
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 analysis
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.
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.
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.
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 analysis
Quality of life assessment
Difference between baseline and 6-month values for quality of life as assessed by the KCCQ, the Minnesota Living with Heart Failure Questionnaire, PGA and EQ-5D-5L. KCCQ: score from 0 to 100 Minnesota Living with Heart Failure Questionnaire: total score ranges from 0 to 105, with higher scores indicating a worse quality of life and greater impact from heart failure PGA: only one question EQ-5D-5L: Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems Mean difference with 95% CI. Paired plot (spaghetti plot) showing baseline values, values at 3 months and values at 6 months.
Time frame: 6 months [± 15 days] - complete-case analysis
Survival
6-month mortality rate. Restricted Mean Survival Time, Kaplan-Meier curve
Time frame: 6 months [± 15 days] - complete-case analysis
Changes in biomarkers
Difference between baseline and 6-month values for NT-proBNP and troponin. Mean difference with 95% CI. Paired plot (spaghetti plot) showing baseline, 3-month and 6-month values.
Time frame: 6 months [± 15 days] - complete-case analysis
Functional capacity during exercise
Difference between the baseline value and the 6-month value of the 6-minute walk test Difference in mean with 95% CI. Paired plot (spaghetti plot) showing the baseline value, the 3-month value and the 6-month value.
Time frame: 6 months [± 15 days] - complete-case analysis
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2029, 30 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 30 months is close to that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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