Low-dose beta-blocker treatment for adults who survived unexplained ventricular fibrillation

Investigation of RIsk Factors in Out-of-hospital-cardiac-arrest Patients, and MEdical Treatment in Idiopathic Ventricular Fibrillation Patients

This trial will try low-dose beta-blockers in adults who survived an out-of-hospital cardiac arrest with no clear cause to see if it reduces dangerous heart rhythms and ICD therapies.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 2 sites (Copenhagen, Dr. and 1 other locations)
• Trial ID: NCT07405229 on ClinicalTrials.gov

What this trial studies

This interventional Phase 4 protocol gives low-dose beta-blocker therapy to adults resuscitated from out-of-hospital cardiac arrest who have no identifiable cause (idiopathic ventricular fibrillation). The primary aim is to determine whether beta-blocker treatment reduces arrhythmic events and appropriate ICD therapies during follow-up. The study also collects toxicology and genetic profiles and applies machine-learning analyses of repolarization patterns to search for predictors of recurrent arrhythmia or ICD therapy. Patients with ischemic or congenital heart disease or a clear non-cardiac cause are excluded, and recruitment occurs at two Danish tertiary centers.

Who should consider this trial

Good fit: Adults (≥18) resuscitated from out-of-hospital cardiac arrest with a suspected cardiac cause but no identified ischemic or congenital heart disease who are treated at participating Danish centers and understand Danish.

Not a fit: Patients with ischemic heart disease, an obvious non-cardiac cause of arrest, congenital heart disease, those who cannot speak Danish or are foreign visitors, or those with contraindications to beta-blockers are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, low-dose beta-blockers could lower the risk of recurrent dangerous heart rhythms and reduce ICD shocks or therapies in patients with idiopathic VF.

How similar studies have performed: Medical treatment in idiopathic ventricular fibrillation has not been systematically tested, and while some patients are treated empirically with beta-blockers, this approach remains largely unproven in formal studies.

Eligibility criteria

Inclusion Criteria:

Resuscitated OHCA patients admitted to one of the participating hospitals.

1. Age ≥18 years
2. Suspected cardiac cause of cardiac arrest

Exclusion Criteria:

OHCA patients

1. With Ischemic heart disease.
2. Obvious non-cardiac cause of cardiac arrest
3. Congenital heart disease
4. Do not speak or understand Danish
5. Foreigners -

Where this trial is running

Copenhagen, Dr. and 1 other locations

• The Heart Center, Rigshospitalet — Copenhagen, Dr., Denmark (Recruiting)
• Odense University Hospital — Odense, Denmark (Not_yet_recruiting)

Study contacts

• Principal investigator: Bo G Winkel, MD — The Heart Center, Rigshospitalet
• Study coordinator: Bo G Winkel, MD, PhD

Conditions Idiopathic Ventricular Fibrillation; Cardiac Arrest, Out-Of-Hospital; IVF; cardiac arrest; beta-blocker; treatment; ventricular tachyarrhythmias; Risk markers