Actively Recruiting
Investigation of Risk Factors in Out-of-hospital Cardiac Arrest Patients and Medical Treatment in Idiopathic Ventricular Fibrillation Patients
Led by Bo Gregers Winkel · Updated on 2026-02-12
218
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
B
Bo Gregers Winkel
Lead Sponsor
T
The Novo Nordisk Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying people who have survived a cardiac arrest with no clear cause, specifically focusing on those with idiopathic ventricular fibrillation (IVF). These patients face a risk of having another cardiac arrest, and while implantable cardioverter-defibrillators (ICDs) are commonly used to prevent recurrence, the best medical treatment and ways to identify high-risk patients are not well established. This research aims to evaluate the effect of beta-blocker treatment on reducing irregular heart rhythms and to explore new risk assessment methods using genetic, toxicological, and advanced ECG data, along with assessing quality of life in these patients. The study compares two groups of patients: one receiving beta-blocker treatment and one receiving no medication. The beta-blocker group will be given either a non-selective beta-blocker such as Propranolol Retard 80 mg daily or Nadolol 40 mg daily, or a selective beta-blocker like Atenolol 25 mg daily, Bisoprolol 2.5 mg daily, or Metoprolol 50 mg daily. Standard care is provided to all participants, and the study is randomized and single-blinded. Participants will be observed for up to three years after discharge, with the primary outcome being the first appropriate ICD therapy or the three-year mark. Quality of life will be assessed at three months and one year. Researchers will also collect data on genetic and toxicological profiles and analyze ECG patterns using machine learning to improve risk prediction. The study began in May 2018 and plans to continue until December 2035, offering long-term monitoring and evaluation of these patients' health and treatment impacts.
CONDITIONS
Brief Title
MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resuscitated out-of-hospital cardiac arrest patients admitted to participating hospitals
- Age 18 years or older
- Suspected cardiac cause of cardiac arrest
You will not qualify if you...
- Patients with ischemic heart disease
- Patients with obvious non-cardiac cause of cardiac arrest
- Patients with congenital heart disease
- Patients who do not speak or understand Danish
- Foreigners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years or until study completion
Participants are randomly assigned to receive either beta-blocker medication or no medication and are treated accordingly.
Trial Site Locations
Total: 2 locations
1
The Heart Center, Rigshospitalet
Copenhagen, Dr., Denmark, 2100
Actively Recruiting
2
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
B
Bo G Winkel, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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