Low Dose Radiotherapy for Heart Failure

NCT07037524 | Not Yet Recruiting Phase 1

• 1 other identifier: RadioCardio
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure - NYHA II - IV

Keywords

Heart Failure; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the Left Ventricular Ejection Fraction

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

  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.

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

Study Arms (1)

Single arm

EXPERIMENTAL

Low Dose Radiotherapy

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Low single-dose wholw-heart radiotherapy

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Financiadora de Estudos e Projetos: collaborator

Study Sites (1)

Hcor / Associação Beneficente Síria

São Paulo, 04004-030, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: July 14, 2025
• Primary Completion: December 20, 2025
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after the publicationof the article.
• Access Criteria: Detailed planned analysis from actives researchers in the topic.

Locations

BR (1)