Heart Failure - NYHA II - IVPhase 1/2RadioCardioNCT07037524
Low Dose Radiotherapy for Heart Failure
A Phase 1/2 study testing Radiation Therapy in people with Heart Failure - NYHA II - IV, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
The primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction in ten participants with advanced heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure - NYHA II - IV
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jul 2025to 30 Sep 2030
- Phase
- Phase 1/2
- 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
- Age >18 years;
- Clinical and laboratory diagnosis of chronic systolic HF grades II or III of the New York Heart Association with ejection fraction <40%;
- Refractoriness to standard clinical treatment; defined as the persistence of HF signs and symptoms despite optimized drug therapy.
- Patient consent to participate in the study.
- Agreement to adopt contraceptive practices/methods until the end of the intervention for women of childbearing age.
Who cannot join
- Patients who have undergone any type of previous radiotherapy in the thoracic region;
- Patients who have undergone heart transplants;
- Contraindications for magnetic resonance imaging (MRI), such as the use of metal implants or prostheses.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hcor / Associação Beneficente Síria
São Paulo, 04004-030
Alexandre B Cavalcanti, MD, Ph.D, 55 11 3053-6611, abiasi@hcor.com.br
Tamiris A Miranda, RPh, M.Sc, 55 11 3053-6611, tabait@hcor.com.br
About this study
Official title: Prospective Pilot Single-center Study to Evaluate the Safety and Efficacy of Low-dose Radiotherapy in Patients With Heart Failure
The primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction in ten participants with advanced heart failure.
Read the detailed description
The primary objectives of this prospective phase I/II, single-center study, are to evaluate the safety and efficacy of low dose whole-heart radioherapy (RT) in ten patients with heart failure (HF).
Eligible patients must have clinical-laboratory diagnosis of New York Heart Association grade II or III chronic systolic HF with ejection fraction < 40% and refractoriness to standard clinical treatment defined as the persistence of signs and symptoms of HF despite optimized drug therapy.
All subjects will receive whole-heart RT for a single-dose of 5 Gy. The primary efficacy endpoint will be determined by evaluating the impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI. Radioinduced toxicity results (pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
All patients will undergo more comprehensive clinical, laboratory and imaging evaluation at 2 time points: up to 2 weeks before and 12 weeks after RT. At each moment, a clinical evaluation will be carried out, blood tests will be checked (blood count and serum levels of urea, creatinine, sodium, potassium, calcium, albumin, magnesium, troponin, creatine kinase MB, C-reactive protein and type B natriuretic peptide) and echocardiography will be performed. Cardiac MRI will be performed just 4 weeks after RT.
Although the risk of late toxicity from RT is low due to the dose administered and high short-term mortality associated with HF itself, all patients will be followed by the research group after the period of additional clinical-laboratory evaluations scheduled in the first 12 weeks after RT. After 12 weeks, all patients will be followed by the research group for clinical-laboratory evaluation every 6 months. Considering the median survival reported in this group of patients, approximately 2 years, the estimated total duration of the study is 5 years.
- Conditions
- Heart Failure - NYHA II - IV
- Being tested
- Radiation Therapy
- Keywords
- 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.
Radiation TherapyRadiation
Low single-dose wholw-heart radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Low Dose Radiotherapy Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Left Ventricular Ejection Fraction
Impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI
Measured: 4 weeks after radiotherapy
Treatment-related Adverse Effects as assessed by CTCAE v5.0
Pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Evaluation at 2, 4, 12 weeks and every 6 months unti 5 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start14 Jul 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure - NYHA II - IVStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-center
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037524
- Sponsor's protocol ID
- RadioCardio
- Acronym
- RadioCardio
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) and Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Single-center Study to Evaluate the Safety and Efficacy of Low-dose Radiotherapy in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07037524
- Acronym / sponsor ID
- RadioCardio / RadioCardio
- Conditions
- Heart Failure - NYHA II - IV
- Keywords
- Heart Failure, Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 25 Jun 2025 (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 primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction in ten participants with advanced heart failure.
Detailed description
The primary objectives of this prospective phase I/II, single-center study, are to evaluate the safety and efficacy of low dose whole-heart radioherapy (RT) in ten patients with heart failure (HF).
Eligible patients must have clinical-laboratory diagnosis of New York Heart Association grade II or III chronic systolic HF with ejection fraction < 40% and refractoriness to standard clinical treatment defined as the persistence of signs and symptoms of HF despite optimized drug therapy.
All subjects will receive whole-heart RT for a single-dose of 5 Gy. The primary efficacy endpoint will be determined by evaluating the impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI. Radioinduced toxicity results (pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
All patients will undergo more comprehensive clinical, laboratory and imaging evaluation at 2 time points: up to 2 weeks before and 12 weeks after RT. At each moment, a clinical evaluation will be carried out, blood tests will be checked (blood count and serum levels of urea, creatinine, sodium, potassium, calcium, albumin, magnesium, troponin, creatine kinase MB, C-reactive protein and type B natriuretic peptide) and echocardiography will be performed. Cardiac MRI will be performed just 4 weeks after RT.
Although the risk of late toxicity from RT is low due to the dose administered and high short-term mortality associated with HF itself, all patients will be followed by the research group after the period of additional clinical-laboratory evaluations scheduled in the first 12 weeks after RT. After 12 weeks, all patients will be followed by the research group for clinical-laboratory evaluation every 6 months. Considering the median survival reported in this group of patients, approximately 2 years, the estimated total duration of the study is 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-center
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: Radiation TherapyLow Dose Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years;
- Clinical and laboratory diagnosis of chronic systolic HF grades II or III of the New York Heart Association with ejection fraction <40%;
- Refractoriness to standard clinical treatment; defined as the persistence of HF signs and symptoms despite optimized drug therapy.
- Patient consent to participate in the study.
- Agreement to adopt contraceptive practices/methods until the end of the intervention for women of childbearing age.
Key exclusion criteria (4 listed)
- Patients who have undergone any type of previous radiotherapy in the thoracic region;
- Patients who have undergone heart transplants;
- Contraindications for magnetic resonance imaging (MRI), such as the use of metal implants or prostheses.
- Pregnant patients.
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 |
|---|---|---|
| Radiation TherapyLow single-dose wholw-heart radiotherapy | Radiation | Single arm |
Primary outcome
Change from Baseline in the Left Ventricular Ejection Fraction
Time frame: 4 weeks after radiotherapy
Impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI
Treatment-related Adverse Effects as assessed by CTCAE v5.0
Time frame: Evaluation at 2, 4, 12 weeks and every 6 months unti 5 years after radiotherapy
Pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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 25 Jun 2025.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) and Analytic Code
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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 Phase 1/2 study testing Radiation Therapy in people with Heart Failure - NYHA II - IV, run by Hospital do Coracao at 1 site in Brazil.
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 5 inclusion and 4 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 25 Jun 2025. 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 Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Left Ventricular Ejection Fraction (time frame: 4 weeks after radiotherapy). The study lists 2 primary outcomes in all. 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 25 Jun 2025.