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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001683-37 | EudraCT Number | ||
| H-18017757 | Other Identifier | The Regional Research Ethics Committees Denmark |
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| Name | Class |
|---|---|
| The Novo Nordisk Foundation | UNKNOWN |
| Per Henriksen Foundation | UNKNOWN |
| Danish Heart Foundation | OTHER |
| RH research funds |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-blocker | Active Comparator |
| |
| No medication | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Resuscitated OHCA patients admitted to one of the participating hospitals.
Exclusion Criteria:
OHCA patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo G Winkel, MD, PhD | Contact | +4535459759 | bo.winkel@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bo G Winkel, MD | The Heart Center, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center, Rigshospitalet | Recruiting | Copenhagen | Dr. | 2100 | Denmark |
GDPR
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| ID | Term |
|---|---|
| C537182 | Paroxysmal ventricular fibrillation |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
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| UNKNOWN |
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| 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 |
| Odense University Hospital | Not yet recruiting | Odense | 5000 | Denmark |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |