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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Name of medicine, other:
  Landiolol 300 mg powder for solution for infusion (Landiolol hydrochloride lyophilized powder 300 mg/50 ml)
• Anatomical Therapeutic Chemical (ATC) code:
  (C07AB14) landiolol

  landiolol
• Medical condition to be studied:
  Supraventricular tachycardia

  Atrial fibrillation

  Atrial flutter

  Sinus tachycardia

Population studied

• Short description of the study population:
  The study population consists of adults (age 18 years old and over) patients receiving Landiolol for the treatment of supraventricular tachycardia, the rapid control of ventricular rate in atrial fibrillation or atrial flutter, other circumstances where the short-term control of the ventricular rate with a short acting agent is desirable, or non-compensatory sinus tachycardia.
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  450

Study design details

• Study design:
  A retrospective-prospective, multicenter, multinational observational study designed for patients suitable for Landiolol treatment in a hospital setting to assess drug utilization patterns. The study will not interfere with the usual patient care.
• Main study objective:
  Primary Study Objective: ; - to characterize the drug utilization patterns in patients who were treated with Landiolol according to the SmPC; ; Secondary Study Objectives:; - to evaluate effectiveness of Landiolol treatment 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
• Setting:
  Having already been deemed suitable by their physicians for treatment with Landiolol, patients are treated intravenously in a peri-, postoperative, intensive care or emergency care setting, to assess drug utilization pattern, effectiveness, safety, patient characteristics and follow-up data on major adverse cardiac events up to 180 days.; The decision to initiate treatment with Landiolol will be the physician's responsibility and should be in accordance with the prescribing recommendation in the particular country. For each eligible patient, informed consent must be obtained (or a waiver is given, if the patient had died during Landiolol treatment, or were not capable of consenting) before entering data into the study electronic database. Patients could also be enrolled retrospectively, as long as treatment occurred after full regulatory approval and site activation.
• Outcomes:
  The study protocol does not assign treatments, nor does it dictate what medical information should be entered into patient charts. Rather, each participating site provides and documents patient care and outcomes according to usual care, physician discretion and local practice standards. Thus, study variables may not be available for all patients at all time points, if data are not recorded in the chart as per routine medical care.;

Documents

Study report

LANDI-UP_Clinical Study Report_V1.0_English_17Sep2024_redacted.pdf