MedPath

Low Dose Radiotherapy for Heart Failure

Phase 1
Not yet recruiting
Conditions
Heart Failure - NYHA II - IV
Registration Number
NCT07037524
Lead Sponsor
Hospital do Coracao
Brief 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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Change from Baseline in the Left Ventricular Ejection Fraction4 weeks after radiotherapy

Impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hcor / Associação Beneficente Síria

🇧🇷

São Paulo, Brazil

Hcor / Associação Beneficente Síria
🇧🇷São Paulo, Brazil

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