A retrospective-prospective observational study to assess Landiolol utilization patterns in patients with supraventricular tachycardia, for rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter, for short-term control of the ventricular rate, or for non-compensatory sinus tachycardia (LANDI-UP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000297
• EU PAS number:
  EUPAS1000000297
• Study ID:
  1000000297
• Official title and acronym:
  A retrospective-prospective observational study to assess Landiolol utilization patterns in patients with supraventricular tachycardia, for rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter, for short-term control of the ventricular rate, or for non-compensatory sinus tachycardia (LANDI-UP)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Germany

  Greece

  Hungary

  Netherlands

  Poland

  Slovenia
• Study description:
  A post-marketing, retrospective-prospective mulicenter, multinational non interventional study.; Primary Objective: To characterize Landiolol utilization patterns in patients treated according to the SmPC.; Primary Endpoint: Landiolol utilization patterns (total dose, infusion duration, starting/minimum/maximum dose, application route (central/peripheral line). ; Secondary Objectives: ; - to evaluate Landiolol effectiveness in a real-world setting; - to evaluate characteristics of patients treated with Landiolol intravenously in a real-world setting; - to evaluate the safety of patients treated with Landiolol intravenously in a real-world setting to facilitate life-cycle risk-benefit profiling; - to assess length of intensive/emergency care and hospital stay; - to survey the major cardiac outcome of patients treated with Landiolol up to 180 days ; Secondary Endpoints:; Patient characteristics including medical history, reason for Landiolol use, left ventricular ejection fraction and use of concomitant medications; Efficacy data assessed within 4 hours after Landiolol discontinuation based on: ; - percentage of patients with a heart rate control ≤ 110 beats per minutes (bpm) or 20% less than baseline ; - percentage of patients with a heart rate control ≤ 90 bpm; - percentage of patients who recover the normal sinus rhythm; - proportion of patients requiring additional pharmacological or electrical cardioversion for rhythm control during hospital stay; Safety data up to 180 days after Landiolol initiation:; - adverse events (AEs) concerning number of patients and events, incidence rate, seriousness, intensity and relationship to study drug ; - AEs requiring discontinuation of the treatment or treatment with specific therapy; - length of Intensive Care Unit (ICU)/Emergency Care Unit (ECU) and hospital stay; - major adverse cardiac events (MACE) by type: transient ischemic attack or ischemic stroke, myocardial infarction (STEMI and NSTEMI), cardiovascular death, all-cause mortality, etc.
• Study status:
  Finalised

Research institutions and networks

Institutions

AOP Orphan Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 19/04/2020

Study start date

Planned: 09/07/2020

Actual: 09/07/2020

Date of final study report

Planned: 22/08/2024

Actual: 09/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AOP Orphan Pharmaceuticals GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable