Cardiac Arrest, Out-Of-Hospital, Idiopathic Ventricular Fibrillation
Conditions
Keywords
Idiopathic Ventricular Fibrillation, IVF, cardiac arrest, beta-blocker, treatment, ventricular tachyarrhythmias, Risk markers, quality of life, QoL
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.
Interventions
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
Bo Gregers Winkel
Novo Nordisk Foundation
Danish Heart Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First appropriate therapy by ICD or 3 years after discharge | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life at 3 months | 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. |
| Quality of Life at 1 year | 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. |
Countries
Denmark
Contacts
CONTACTBo G Winkel, MD, PhD
PRINCIPAL_INVESTIGATORBo G Winkel, MD
The Heart Center, Rigshospitalet
Outcome results
None listed