Bisoprolol fumarate, hydrochlorothiazide for Idiopathic ventricular fibrillation | Out-of-hospital cardiac arrest (unexplained cardiac arrest)

Inclusion criteria

• {"criterion_text":"- Unexplained cardiac arrest survivors aged 18 or older\n- All patients surviving a cardiac arrest will receive a minimum diagnostic work-up consisting of an ECG, a Holter monitor during admission, an echocardiography, consecutive blood samples during the first 24 hours, and a coronary angiography or a cardiac CT-scan. Further evaluation with SAECG, stress-ECG, Cardiac MRI, and Sodium-channel blocker testing will be performed subsequently\n- All patients will have an ICD implanted"}

Exclusion criteria

• {"criterion_text":"- Age under 18 years\n- Explained cardiac arrest"}

Primary endpoints

• {"endpoint_text":"- Endpoint will be one of the following 1) first appropriate therapy by ICD, 2) aborted shock or non-sustained VF, where the treating physician opts XML File Identifier: kg77bYwzweR7n2lb9bLtT2kXLeo= Page 25/34 for a change in medication, or 3) 3 years after randomizationdischarge, whichever comes first.","definition_or_measurement_approach":"Measured by ICD events (first appropriate therapy by ICD), aborted shock or non-sustained ventricular fibrillation leading to change in medication, or by time (3 years after randomization/discharge)."}

Secondary endpoints

• {"endpoint_text":"- Quality of life after 1 year","definition_or_measurement_approach":"Not specified in the record."}

Denmark

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

12

Number Of Sites

2

Number Of Participants

218

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Sponsor duties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}