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SBRT-CHF trial

Prospective Study about Reverse Remodeling Effect of Stereotactic Body Radiotherapy in Chronic Heart Failure with Refractory Ventricular Arrhythmia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250005
Enrollment
10
Registered
2025-04-10
Start date
2025-08-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure with ventricular arrhythmia Refractory ventricular arrhythmia,chronic heart failure

Interventions

Arrhythmia treatment by external radiation using X-ray equipment for cancer treatment

Sponsors

Yoshioka Koichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Written consent to participate in the study has been obtained from the individual or a substitute 2)18 years of age or older 3)Have an implantable cardioverter defibrillator (ICD or CRTD) implanted 4)Chronic heart failure complicated by refractory ventricular arrhythmias (1) Sustained monomorphic ventricular tachycardia with 3 or more episodes, complicated by heart failure (HFrFF or HFpEF) (2) Cardiomyopathy resulting from ventricular premature beats (more than 20% of total heart beats) (HFrEF, EF less than 50%) Any of the above conditions with the following conditions Resistance to at least one antiarrhythmic drug or difficulty in taking them Patients with a history of at least one catheter ablation ,or non-eligible for catheter ablation or refusal of catheter ablation. 5) Regardless of whether you are hospitalized or outpatient

Exclusion criteria

Exclusion criteria: Heart failure dependent on left ventricular assist devices. Patients who are not expected to survive longer than 12 months due to factors other than VT. Polymorphic VT or ventricular fibrillation. Patients with three or more different clinical modes of VT. Structure heart disease requiring surgical treatment. Patients requiring inpatient treatment for acute coronary syndromes. High risk of radiation pneumonitis, e.g. with clear evidence of idiopathic pulmonary fibrosis on chest CT People with dementia, mental illness, or who require care. The principal investigator and assistant investigator judges that the patient is not suitable to participate in this study because of other diseases or reasons that make it difficult to carry out the necessary examinations or follow-up investigations.

Design outcomes

Primary

MeasureTime frame
1) Effectiveness Antiarrhythmic effect: Decrease in ventricular arrhythmias, decrease in ICD shock activation. Effect on cardiac function: Increase in ejection fraction, decrease in BNP. 2) Safety Radiation injury

Secondary

MeasureTime frame
Inhibition of sympathetic hyperactivity

Contacts

Public ContactMari Amino

TOKAI UNIVERSITY SCHOOL OF MEDICINE HOSPITAL

mariamino@tokai.ac.jp+81-463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026