Health TrialsbyHealthPanel

MEdical Treatment in Idiopathic Ventricular Fibrillation Patients

ConditionsIdiopathic Ventricular FibrillationCardiac Arrest, Out-Of-Hospital
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBo Gregers Winkel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Suspected cardiac cause of cardiac arrest

Disqualifiers

With Ischemic heart disease.

Obvious non-cardiac cause of cardiac arrest

Congenital heart disease

Do not speak or understand Danish

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beta-blocker treatment group

    Drug

    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.

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Beta-blockerActive comparator 1 intervention
Group B: No medicationNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bo Gregers Winkel

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Novo Nordisk Foundation

Collaborator

Danish Heart Foundation

Collaborator

Source ClinicalTrials.gov
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