Not Yet RecruitingPhase 1/2

Low Dose Radiotherapy for Heart Failure

Brazil10 participantsStarted 2025-07-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * 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. Exclusion Criteria * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in the Left Ventricular Ejection Fraction

Timeframe: 4 weeks after radiotherapy

Treatment-related Adverse Effects as assessed by CTCAE v5.0

Timeframe: Evaluation at 2, 4, 12 weeks and every 6 months unti 5 years after radiotherapy

Trial details

NCT IDNCT07037524

SponsorHospital do Coracao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Heart Failure - NYHA II - IV trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.