Assessment of Real LIfe cAre – Describing EuropeaN Heart FailurE Management (ARIADNE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Patient characterization in terms of demographics, medical history, HF status, comorbidity burden
• 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:
  Chronic left ventricular failure

Population studied

• Short description of the study population:
  The present study wil include consecutive HFrEF patients treated by office based cardiologists or selected primary care physicians across Europe.; Inclusion criteria:; 1. Written informed consent provided by the patient or legal representative for participting in the study; 2. Age 18 years or older; 3. Patient with symptomatic CHF with a documented reduce left ventricular ejection fraction (LVEF) as assessed by clinical examination and any imaging technique performed anytime in the past
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic left ventricular failure patients
• Estimated number of subjects:
  12000

Study design details

• Main study objective:
  To describe the demographic and clinical features of HFrEF patients managed in the outpatient sector and the diagnostic and pharmacological interventions they receive and the demographic and clinical features of patients for whom treating physician decided to start sacubitril/valsartan, the pattern of administration of this drug, the diagnostic and therapeutic interventions these patients receive
• Outcomes:
  - Descriptive analysis of baseline characteristics of patients initiated on sacubitril/valsartan and patients continued on SoC in outpatient sector - Descriptive analysis of profile of sacubitril/valsartan patients not reaching and maintaining target dose of 200mg twice daily in terms of demographics, medical history, HF status, comorbidity burden as compared with patients reaching target dose, - describe the overall HFrEF population managed in the outpatient sector in Europe- describe HF-treatment in the outpatient sector in Europe- describe the starting dose, titration and maintenance dose of sacubitril/valsartan in patients with different anamnestic and demographic characteristics- describe safety and tolerability features of sacubitril/valsartan in real-world HF patients
• Data analysis plan:
  Only descriptive data analyses will be carried out, supported by calculation of confidence intervals. No statistical testing will be performed. Analyses will be performed for the total sample and stratified by demographic, anamnestic and medical factors (e.g. sex, duration of HF, severity of HF, previous HF-treatment), using an adequate grouping. As appropriate, analysis of all endpoints will also be carried out after stratification according to CHF treatment during the observation period.

Documents

Study results

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