DARWIN EU® - Representativeness of the clinical trial population compared with the real-world population with resistant hypertension

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Additional medical condition(s):
  resistant hypertension

Population studied

• Short description of the study population:
  For characterisation (objectives 1–2), the study population will include adults with resistant hypertension identified within routinely collected healthcare data
• 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)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 7 data sources across 6 countries, including 5 European Union (EU) member states and the United States.
• Main study objective:
  1. To determine the extent to which the resistant hypertension trial population reflects the real-world resistant hypertension population by comparison of demographic (age, sex), clinical, and treatment characteristics observed in the clinical trial with those derived from real-world data sources.; 2. To characterise patients with resistant hypertension, including but not limited to age, sex, BMI/obesity status, chronic kidney disease stage, diabetes, atrial fibrillation, cardiovascular disease (aldosteronism), current treatment of care, and other relevant comorbidities.;