Assessing the profile of CHF patients with redUced ejection fraction being managed in the pRimary care sectOr across GeRmany as well as the phArmacologic treatment these HF patients receive (AURORA-HF)

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SACUBITRIL

  VALSARTAN
• Medical condition to be studied:
  Cardiac failure chronic

Population studied

• Short description of the study population:
  Chronic heart failure (CHF) patients in Germany.
• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  13056

Study design details

• Main study objective:
  AURORA-HF will provide a picture of HFrEF patients being managed in the primary care sector across Germany. It will describe the pharmacologic treatment HFrEF patients receive, the demographic and clinical features of patients who will be started on Sacubitril/Valsartan and the demographic and clinical features of patients, who will receive Sacubitril/Valsartan as long-term therapy.
• Outcomes:
  ─ To describe the profile of patients initiated on Sacubitril/Valsartan as compared to conventionally treated patients ─ To describe the profile of Sacubitril/Valsartan patients who remain on Sacubitril/Valsartan therapy until the final visit (approx. 12 months) as compared to those who permanently stop Sacubitril/Valsartan therapy
• Data analysis plan:
  The data will be analyzed by Novartis and/or by the designated CRO. All data will be analyzed descriptively. Probability of remaining on treatment until month 12 will be modelled using logistic regression. The following baseline characteristics will be fitted in the model as factors in order to determine the baseline characteristics which best describe the profile of patients who will remain on treatment:─ SBP (<110 mmHg, 110 – 120 mmHg, >120 mmHg)─ Age (<75 years, ≥75 years)─ Renal function (eGFR < 60, eGFR >= 60)─ Concomitant medications─ Beta-blocker (yes/no)─ MRA (yes/no)─ Diuretics (yes/no)─ NYHA class (II, III/IV)─ Hospitalization for HF within the year prior to enrollment