Retrospective Observational non-interventional chart review study of patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) in Finland (FINPAH)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, non-interventional retrospective patient chart review study

Study drug and medical condition

• Medical condition to be studied:
  Pulmonary arterial hypertension

  Pulmonary hypertension

Population studied

• 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

• Main study objective:
  The primary aim is to investigate the real-life patient characteristics, treatment patterns and clinical outcomes of PAH and CTEPH patients in Finland
• Outcomes:
  1. Patient characteristics and risk groups as defined by ESC/ERS risk assessment parameters. 2. Used treatments and treatment pathways (e.g. procedures, medication, posology, treatment duration, switch patterns or discontinuation incl. possible reason). Outcomes (e.g. annualized resource use) and treatment effects defined as comparing assessments at diagnosis of PAH (baseline) and at follow-ups (potential differentiation between ERAs as derived outcomes).
• Data analysis plan:
  Analysis will include basic statistical analysis methods aimed to describe the results. More advanced methods (e.g. multivariate modelling) may be used and subgroup analysis can be performed, if sample size and information collected is enough for such analysis. Reporting of all data is conditional of having enough observations (absolute minimum is 5 observations).