MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beta-blocker treatment group.
- Who it may be relevant to
- Registry conditions: Idiopathic Ventricular Fibrillation, Cardiac Arrest, Out-Of-Hospital. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of RIsk Factors in Out-of-hospital-cardiac-arrest Patients, and MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
Overview
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.
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.
Primary outcome measures
- First appropriate therapy by ICD or 3 years after discharge [Time frame: 3 years]
Secondary outcome measures (2)
- Quality of Life at 3 months [Time frame: 3 months]
- Quality of Life at 1 year [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
Resuscitated OHCA patients admitted to one of the participating hospitals.
- Age ≥18 years
- Suspected cardiac cause of cardiac arrest
Exclusion criteria
OHCA patients
- With Ischemic heart disease.
- Obvious non-cardiac cause of cardiac arrest
- Congenital heart disease
- Do not speak or understand Danish
- Foreigners -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- The Heart Center, Rigshospitalet — Copenhagen
- Odense University Hospital — Odense
Identifiers
NCT: NCT07405229 · 2024-518057-41-00 · 2018-001683-37 · H-18017757