Low Dose Radiotherapy for Heart Failure
ConditionHeart Failure - NYHA II - IV
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Coracao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Radiation Therapy
RadiationLow single-dose wholw-heart radiotherapy
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Left Ventricular Ejection Fraction
Impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI
Time frame
4 weeks after radiotherapy2
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.
Time frame
Evaluation at 2, 4, 12 weeks and every 6 months unti 5 years after radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital do Coracao
Lead sponsor
Financiadora de Estudos e Projetos
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: