Estudio de utilización de medicamentos para el tratamiento de la insuficiencia cardíaca (IDIAP-IC-2025) / Drug utilization study of treatments for heart failure (IDIAP-IC-2025)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Drugs for heart failure treatment
• Medical condition to be studied:
  Heart failure with reduced ejection fraction

  Heart failure with midrange ejection fraction

  Heart failure with preserved ejection fraction

Population studied

• Short description of the study population:
  Adults with diagnosis of heart failure registered in the Primary Care electronic records of 12 Autonomous Communities in Spain from 2018 to 2024.
• 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:
  300000

Study design details

• Study design:
  Descriptive population-based cohort study
• Main study objective:
  To describe sociodemographic and clinical characteristics of people with heart failure and the pharmacological treatment used
• Setting:
  Primary Care of 12 regions of Spain covered by BIFAP database, with prevalent and incident diagnoses from 2018 to 2024.
• Comparators:
  Not applicable
• Outcomes:
  The variables that will be collected during patient follow-up in the study period are: exposure to drugs of interest used in the treatment of HF (treatment changes, persistence), hospitalizations due to HF decompensation (CMBD hospital discharge diagnoses), and all-cause mortality.; Hospitalizations due to decompensation prior to entry into the study cohort will be collected in order to analyze the background, as well as those that occur during the entire follow-up period of patients from the time they are included in the cohort. Hospitalizations due to HF decompensation will be defined as those with a diagnosis of HF and related symptoms (pulmonary edema, nonspecific hepatomegaly, cardiogenic shock, and nonspecific edema) that occur during the follow-up period. For both HF decompensations and all-cause mortality during follow-up, incidence rates will be calculated.
• Data analysis plan:
  Population characteristics will be described using absolute frequency and percentage for categorical variables, and using mean and standard deviation (SD) and/or median and interquartile range (IQR) for continuous variables, depending on their distribution.; Incidence rates (IR) will be estimated for all-cause mortality and hospital admission due to disease decompensation. The risk of events between groups will be compared using the IR rate (IRR), both crude and adjusted for relevant variables. These values will be presented together with their point estimate and 95% confidence interval (CI).; The results will be presented comprehensively for the entire population, as well as stratified by sex.; Analytical methods will be used to control for confounding variables.; All analyses will be performed using version 4.2 or higher of the R statistical package.