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Landiolol for improved outcome in cardiac arrest

Beta-blockade with landiolol in out-of-hospital cardiac arrest: a randomized, double-blind, placebo-controlled, pilot trial - Beta-blockade in cardiac arrest

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2020-003661-19-AT
Enrollment
32
Registered
2020-08-31
Start date
2020-10-27
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

out-of-hospital cardiac arrest

Interventions

Trade Name: Rapibloc® Product Name: Rapibloc Pharmaceutical Form: Powder for concentrate for solution for injection/infusion INN or Proposed INN: LANDIOLOL CAS Number: 133242-30-5 Concentration unit:

Sponsors

Medical University of Vienna
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: OHCA patient, more or equal than 18 years of age Initial shockable rhythm (VF or pVT) as determined by the EMS team Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: Initial rhythm pEA, asystole or unknown Age > 85a Severe head trauma or acute active bleeding Known allergy or insensitivity to landiolol or another beta-blocker No treatment capacity at the emergency department of the Medical University of Vienna

Design outcomes

Primary

MeasureTime frame
Main Objective: We hypothesize that add-on treatment with landiolol in patients with cardiac arrest significantly decreases the time to sustained ROSC (sROSC).;Secondary Objective: We hypothesize that add-on treatment with landiolol in patients with cardiac arrest significantly improves the rate of sustained ROSC, the rate of 30-day survival, number of shocks until sustained ROSC, survival until hospital admission, left ventricular function during ICU stay, mean/median length of stay in ICU, mean/median length of hospital stay, survival until hospital discharge, left ventricular function at discharge, favorable neurologic outcome at hospital discharge (CPC), survival at 3 months, favorable neurologic outcome at 3 months, survival at 6 months, favorable neurologic outcome at 6 months, survival at 12 months and favorable neurologic outcome at 12 months.;Primary end point(s): Time (in minutes) to sustained return of spontaneous circulation;Timepoint(s) of evaluation of this end point: day of inclusion to 12 months

Secondary

MeasureTime frame
Secondary end point(s): the rate of sustained ROSC, the rate of 30-day survival, number of shocks until sustained ROSC, survival until hospital admission, left ventricular function during ICU stay, mean/median length of stay in ICU, mean/median length of hospital stay, survival until hospital discharge, left ventricular function at discharge, favorable neurologic outcome at hospital discharge (CPC), survival at 3 months, favorable neurologic outcome at 3 months, survival at 6 months, favorable neurologic outcome at 6 months, survival at 12 months and favorable neurologic outcome at 12 months.;Timepoint(s) of evaluation of this end point: day of inclusion to 12 months

Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at

Outcome results

None listed

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