The RIME-IVF study Investigation of RIsk factors in out-of-hospital-cardiac-arrest patients, and MEdical treatment in unexplained cardiac arrests survivors

The RIME-IVF study Investigation of RIsk factors in out-of-hospital-cardiac-arrest patients, and MEdical treatment in Idiopathic Ventricular Fibrillation patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001683-37-DK

Enrollment

218

Registered

2018-05-02

Start date

2018-07-03

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained cardiac arrest patients after thorough investigations (Idiopathic ventricular fibrillation, IVF)

Interventions

Trade Name: Propranolol retard Product Name: Propranolol R Product Code: C07AA05 Pharmaceutical Form: Capsule INN or Proposed INN: PROPRANOLOL HYDROCHLORIDE CAS Number: 318-98-9 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unexplained cardiac arrest survivors aged 18 or older. 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. All patients will have an ICD implanted Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Age under 18 years Explained cardiac arrest

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect on beta-blocker treatment in IVF patients by ICD data (appropriate ATP and shock).;Secondary Objective: To assess quality of life in cardiac arrest survivors;Primary end point(s): 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 for a change in medication, or 3) 3 years after randomizationdischarge, whichever comes first.;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: To investigate the effect on beta-blocker treatment in IVF patients by ICD data (appropriate ATP and shock).;Secondary Objective: To assess quality of life in cardiac arrest survivors;Primary end point(s): 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 for a change in medication, or 3) 3 years after randomizationdischarge, whichever comes first.;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): Quality of life;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Denmark

Contacts

Public ContactHjertemedicinsk, KFE, 2142

Rigshospitalet

bo.winkel@regionh.dk4535452142

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026