NCT07405229

MEdical Treatment in Idiopathic Ventricular Fibrillation Patients

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Bo Gregers Winkel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Today, there is no uniform way of approaching prevention of recurrence in idiopathic ventricular fibrillation (IVF) patients, beside ICD implantation. Better reatment and risk stratification tools are needed Medical treatment in these patients has never been assessed systematically, but at least some patients with no apparent diagnosis are on betablocker treatment. It is not known if low-doselow dose betablocker treatment is beneficial in these patients. This study investigates the effect of betablocker treatment to reduce arrhythmic burden in IVF patients. No predictors for appropriate ICD therapy have been identified in patients with IVF. It is also explored if toxicological and/or genetic profiles, together with in depth machine learning simulation data on repolarization patterns from IVF-ECGs compared to controls, can be used as risk stratification tools. Lastly, QOL in IVF patients and the impact of beta blocker treatment will be investigated.

Conditions

• Idiopathic Ventricular Fibrillation
• Cardiac Arrest, Out-Of-Hospital

Interventions

Type	Name	Description
DRUG	Beta-blocker treatment group	The betablocker given to the patient will be prioritized: 1) A non-selective betablocker: Propranolol Retard 80 mg daily or Nadolol 40 mg daily OR 2) A selective betablocker: Atenolol 25 mg daily, Bisoprolol 2.5 mg daily or Metoprolol 50 mg.

Timeline

• Start date: 2018-05-01
• Primary completion: 2032-12-31
• Completion: 2035-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

2 sites across 1 country: Denmark