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MEdical Treatment in Idiopathic Ventricular Fibrillation Patients

NCT07405229 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-09-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Novo Nordisk Foundation

    collaborator OTHER

  • Danish Heart Foundation

    collaborator OTHER

  • Bo Gregers Winkel

    lead OTHER

Principal Investigators

  • Bo G Winkel, MD · The Heart Center, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2032-12-31
Completion
2035-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405229 on ClinicalTrials.gov