NCT07405229

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for phase_4

Timeline
117mo left

Started May 2018

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
May 2018Dec 2035

Study Start

First participant enrolled

May 1, 2018

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

14.7 years

First QC Date

January 26, 2026

Last Update Submit

February 11, 2026

Conditions

Idiopathic Ventricular FibrillationCardiac Arrest, Out-Of-Hospital

Keywords

Idiopathic Ventricular FibrillationIVFcardiac arrestbeta-blockertreatmentventricular tachyarrhythmiasRisk markersquality of lifeQoL

Outcome Measures

Primary Outcomes (1)

  • First appropriate therapy by ICD or 3 years after discharge

    Primary outcome will be either first appropriate therapy by ICD (anti tachycardia pacing or DC conversion), or aborted shock or non-sustained ventricualr fibrillation detected by the ICD, where the treating physician opts for a change in medication, or no therapy from the ICD 3 years after randomization, whichever comes first.

    3 years

Secondary Outcomes (2)

  • Quality of Life at 3 months

    3 months

  • Quality of Life at 1 year

    1 year

Study Arms (2)

Beta-blocker

ACTIVE COMPARATOR
Drug: Beta-blocker treatment group

No medication

NO INTERVENTION

Standard care

Interventions

Beta-blocker treatment groupDRUG

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.

Beta-blocker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resuscitated OHCA patients admitted to one of the participating hospitals.
  • Age ≥18 years
  • Suspected cardiac cause of cardiac arrest

You may not qualify if:

  • OHCA patients
  • With Ischemic heart disease.
  • Obvious non-cardiac cause of cardiac arrest
  • Congenital heart disease
  • Do not speak or understand Danish
  • Foreigners -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Heart Center, Rigshospitalet

Copenhagen, Dr., 2100, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Paroxysmal ventricular fibrillationOut-of-Hospital Cardiac ArrestHeart ArrestTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesTachycardiaArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bo G Winkel, MD

    The Heart Center, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo G Winkel, MD, PhD

CONTACT

+4535459759bo.winkel@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 12, 2026

Study Start

May 1, 2018

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2035

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

GDPR

Locations

DK(2)