Prevalence, Incidence and Patient Characteristics of Chronic Heart Failure (CHF) and the Predicted Subtypes HFrEF(<40%), HFpEF(≥40%) in Japan and United States

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

• Medical condition to be studied:
  Cardiac failure

Population studied

• Short description of the study population:
  The population will include all known heart failure patients within the available data sets from 2014 – 2019. The starting population are any patients included in the Japan Medical Data Center, Medical Data Vision or Optum database with any claims record or insurance registration record during the period of January 1, 2014 to end of data period.; ; Inclusion criteria – Prevalent CHF case:; 1. A code indicating a confirmatory diagnosis of heart failure in JMDC, MDV or Optum database prior to December 31, 2019; 2. For JMDC and MDV, ICD 10 codes to identify heart failure cases will be: cardiac edema (I50.0), chronic congestive heart failure (I50.0), right heart failure (I50.0),; insufficiency of left heart (I50.1), cardiac dyspnea (I50.1), acute cardiac failure (I50.9), cardiac failure (I50.9), chronic cardiac failure (I50.9), cardiogenic pulmonary; edema (I50.0), myocardial failure (I50.9), bi-ventricular failure (I50.9), right ventricular failure (I50.0).; 3. For Optum, at least 2 outpatient diagnosis or 1 inpatient diagnosis will be identified as confirmed cases. The following ICD 9-CM codes in addition to ICD 10 codes above) will be used to identify the CHF population of interest. Congestive heart failure: 428.0, 428.1, 428.2, 428.3, 428.4, 428.9, Heart failure with hypertensive heart disease: 402.01, 402.11, 402.91, Heart failure with hypertensive and renal disease: 404.01, 404.03, 404.11, 404.13, 404.91, 404.93; ; Inclusion criteria – Incident CHF case:; All above codes to identify CHF population will be used for JMDC, MDV and Optum; an incident case will be defined as having no diagnosis of CHF in the preceding 12 months of new CHF diagnosis. Thus, a patient must have at least 12 months of insurance registration data prior to the initial diagnosis date of CHF.; Exclusions:; 1. < 18 years at study entry; 2. Patients with missing or ambiguous age or gender information; 3. Patients with diagnosis code with doubt flag (suspect diagnosis)
• 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:
  Other
• Special population of interest, other:
  Heart failure patients
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  The primary objective of this study is to estimate the prevalence of Japan and US CHF patients using large population based claims and EMR databases. The secondary objectives are to estimate the incidence of CHF patients in Japan and USA, in addition, comparison of CHF patient characteristics and treatment pattern in the two countries will be made.
• Outcomes:
  Crude and standardized prevalence of heart failure in Japan and United States annually and cross year between years 2014 to 2019. Incidence of heart failure Demographics of heart failure prevalent population
• Data analysis plan:
  Primary outcome: prevalence Yearly prevalence over the study period will be calculated as the number of HF patients under follow up on the 30th January each year, divided by the total number of patients under follow up on the December 31st of each year from the JMDC and Optum denominator files. Prevelance will be presented as a crude measure as well as age and gender standardised to account for any changes in age distrubtion across the study period per 1000 persons with 95% confidence interval.