MEdical Treatment in Idiopathic Ventricular Fibrillation Patients (RIME-IVF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Ventricular Fibrillation; Cardiac Arrest, Out-Of-Hospital
• Intervention / Treatment: Drug: Beta-blocker treatment group

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bo G Winkel, MD, PhD; Phone Number: +4535459759; Email: bo.winkel@regionh.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Not yet recruiting
    • Odense University Hospital
    • Contact: Finn L Henriksen, MD
  • Dr.
    • Copenhagen, Dr., Denmark, 2100
      • Recruiting
      • The Heart Center, Rigshospitalet
      • Contact: Bo G Winkel, MD, PhD; Phone Number: 35459759; Email: bo.winkel@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beta-blocker	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.
No Intervention: No medication; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life at 3 months	Quality of life will be assessed by trained nurses. Focus will be on betablocker therapy and overall cognitive abilities after cardiac arrest. Patients will be assessed using the SF-36 (v1) quality of life tool. The patients will be assessed 3 months after discharge.	3 months
Quality of Life at 1 year	Quality of life will be assessed by trained nurses. Focus will be on betablocker therapy and overall cognitive abilities after cardiac arrest. Patients will be assessed using the SF-36 (v1) quality of life tool. The patients will be assessed 3 1 year after discharge.	1 year

Collaborators and Investigators

• Sponsor: Bo Gregers Winkel
• Collaborators: Danish Heart Foundation; The Novo Nordisk Foundation; Per Henriksen Foundation; RH research funds
• Investigators: Principal Investigator: Bo G Winkel, MD, The Heart Center, Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: treatment; QoL; IVF; quality of life; cardiac arrest; beta-blocker; ventricular tachyarrhythmias; Risk markers; Idiopathic Ventricular Fibrillation
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Heart Arrest; Tachycardia, Ventricular; Out-of-Hospital Cardiac Arrest; Paroxysmal ventricular fibrillation
• Other Study ID Numbers: 2024-518057-41-00; 2018-001683-37 (EudraCT Number); H-18017757 (Other Identifier: The Regional Research Ethics Committees Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No