DARWIN EU® - Prevalence of hypertrophic cardiomyopathy (HCM) and obstructive hypertrophic cardiomyopathy (oHCM) in six European countries

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:
  Hypertrophic cardiomyopathy
• Additional medical condition(s):
  Obstructive Hypertrophic cardiomyopathy

Population studied

• Short description of the study population:
  The study population will include all individuals with a first diagnosis of HCM or oHCM (i.e., index date) identified in the database during the study period and with at least one year of medical history.

Study design details

• Study design:
  The study will consist of a retrospective cohort design including patients with a first diagnosis of HCM or oHCM.
• Main study objective:
  1. To estimate the annual prevalence of clinically apparent HCM and oHCM in Europe, overall and stratified by age and sex. ; ; 2. To characterise patients newly diagnosed with HCM and oHCM in terms of demographics, selected HCM-related clinical measurements, and comorbidities existing before, at the time of, and after a first HCM diagnosis. ; ; 3. To describe the frequency of selected HCM-related treatments, including medications, medical devices, and procedures before, at the time of, and after a first HCM diagnosis.;
• Setting:
  This study will be conducted using routinely collected health data from six databases in 6 European countries. All databases were previously mapped to the OMOP CDM.; Data sources:; 1. Clinical Practice Research Datalink (CPRD) GOLD, United Kingdom (UK); 2. Danish Data Health Registries (DK-DHR), Denmark; 3. InGef Research Database (InGef), Germany ; 4. Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP), Spain; 5. Croatian National Public Health Information System (NAJS), Croatia; 6. Norwegian Linked Health Registry data (NLHR), Norway
• Summary results:
  CONCLUSIONS ; This large epidemiological study across six European countries identified a consistent yearly increase in the ; prevalence of clinically recognised HCM. Prevalence was higher among men, although women were older at first recorded diagnosis, suggesting potential delays in diagnosis among them. Essential hypertension, cardiac arrhythmia, ischaemic heart disease, and HF were the most frequently recorded cardiovascular comorbidities and beta-blockers, diuretics, and ACE inhibitors were among the most commonly prescribed medications for both, HCM and oHCM patients. ; Notable variability in the prevalence of HCM, as well as in the frequency of comorbidities, diagnostic measurements, and treatments, was observed across databases, reflecting differences in healthcare settings and data collection methods. Furthermore, the high frequency of cardiovascular comorbidities and HCM-related treatments consistently first recorded more than one year before the index date suggests that HCM may often be diagnosed at a later stage of disease progression. ; These findings enhance our understanding of the burden of this genetic heart disease on healthcare systems across Europe and underscore the ongoing need for increased diagnostic awareness among clinicians to ensure timely diagnosis. The results may help inform the development and evaluation of future screening and management strategies, including the introduction of emerging treatments such as mavacamten.