Heart FailureRADIATE-HFNCT07770230
RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure
A study testing Low-dose cardiac radiation therapy (5 Gy) in people with Heart Failure, run by Rennes University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Low-dose cardiac radiation therapy (5 Gy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age: 18 years
- Ischaemic or non-ischaemic cardiomyopathies
- Optimal medical treatment
- LVEF ≤ 40%
- NYHA class II or III
- Life expectancy > 6 months
Show all 10Show fewer
- At least one hospital admission for heart failure within the 6 months prior to inclusion, or NT-pro BNP ≥ 1,000 pg/mL
- Contraindications to heart transplantation and left ventricular or biventricular assist devices
- Having given their free and informed written consent
- Covered by a health insurance scheme
Who cannot join
- Pregnancy or breastfeeding
- History of thoracic radiotherapy
- History of aortic and mitral valve surgery
- Contraindications to MRI (claustrophobia, presence of metallic foreign bodies)
- Participation in another ongoing interventional study
- Adults subject to legal protection measures (judicial protection, guardianship, curatorship), deprived of their liberty, or unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Rennes University Hospital
Rennes, France, 35000
Guillaume L'Official, MD, 02 99 28 25 25 ext. +33, guillaume.l.official@chu-rennes.fr
Raphaël Martins, MD, 02 99 28 25 41 ext. +33, raphael.martins@chu-rennes.fr
About this study
Official title: RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure: an Exploratory Single-Arm Study
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.
- Conditions
- Heart Failure
- Being tested
- Low-dose cardiac radiation therapy (5 Gy)
- Keywords
- advanced or end-stage heart failure, radiotherapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose cardiac radiation therapy (5 Gy)Radiation
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:
- Pre-treatment assessments,
- Planning and delivery of radiotherapy,
- Post-treatment assessments.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose cardiac radiation therapy (5 Gy) | Experimental | Not described Receives: Radiation: Low-dose cardiac radiation therapy (5 Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months [± 15 days] - complete-case analysis
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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].
Measured: 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
Measured: 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.
Measured: 6 months [± 15 days] - complete-case analysis
Survival
6-month mortality rate.
Restricted Mean Survival Time, Kaplan-Meier curve
Measured: 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.
Measured: 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.
Measured: 6 months [± 15 days] - complete-case analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low-dose cardiac radiation therapy (5 Gy)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770230
- Sponsor's protocol ID
- 35RC24_8825_01_RADIATE-HF
- Other IDs
- 2026-A01293-48, 26.02065.000506
- Acronym
- RADIATE-HF
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure: an Exploratory Single-Arm Study
- ClinicalTrials.gov ID
- NCT07770230
- Acronym / sponsor ID
- RADIATE-HF / 35RC24_8825_01_RADIATE-HF
- Conditions
- Heart Failure
- Keywords
- advanced or end-stage heart failure, radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low-dose cardiac radiation therapy (5 Gy)
| Arm | Type | Receives |
|---|---|---|
| Low-dose cardiac radiation therapy (5 Gy) | Experimental | Radiation: Low-dose cardiac radiation therapy (5 Gy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum age: 18 years
- Ischaemic or non-ischaemic cardiomyopathies
- Optimal medical treatment
- LVEF ≤ 40%
- NYHA class II or III
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- History of thoracic radiotherapy
- History of aortic and mitral valve surgery
- Contraindications to MRI (claustrophobia, presence of metallic foreign bodies)
- Participation in another ongoing interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Low-dose cardiac radiation therapy (5 Gy) |
Primary outcome
Medium-term left ventricular function
Time frame: 6 months [± 15 days] - complete-case analysis
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.
8 secondary outcomes
Ventricular dimensions and function, and the response in terms of myocardial structure and function on MRI
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
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
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
Time frame: 6 months [± 15 days] - complete-case analysis
Quality of life assessment
Time frame: 6 months [± 15 days] - complete-case analysis
Survival
Time frame: 6 months [± 15 days] - complete-case analysis
Changes in biomarkers
Time frame: 6 months [± 15 days] - complete-case analysis
Functional capacity during exercise
Time frame: 6 months [± 15 days] - complete-case analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose cardiac radiation therapy (5 Gy) in people with Heart Failure, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume L'Official, MD (02 99 28 25 25 ext. +33, guillaume.l.official@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medium-term left ventricular function (time frame: 6 months [± 15 days] - complete-case analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.