Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000430

EU PAS number

EUPAS1000000430

Study ID

1000000430

Official title and acronym

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

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Germany
Norway
Spain
United Kingdom

Study description

Hypertrophic cardiomyopathy (HCM) is an inherited heart disease characterised by an increased wall thickness or mass of the left ventricular wall, with a broad clinical spectrum. HCM is classified into two types based on the presence or absence of left ventricular outflow tract (LVOT) obstruction, a distinction that influences patient management. The obstructive form of HCM (oHCM) is observed in approximately 66% of patients.
The prevalence of HCM was initially estimated at 1 in 500 individuals (0.2%) in a U.S. study. Further U.S. and European studies suggest a lower prevalence of clinically diagnosed HCM. In addition, it has been suggested that some individuals may live normal lifespans undiagnosed because the absent of significant symptoms or major interventions.
Estimating the prevalence of HCM is problematic due to several factors, including the relative rarity of the condition, the high proportion of asymptomatic patients, and diagnostic challenges. Large-scale epidemiological studies on the demographics and morbidity burden of HCM in Europe are scarce.
This study aims to estimate the prevalence of HCM and oHCM across several European countries and different healthcare settings.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Albert Prats-Uribe

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-018_Prevalence of HCM and oHCM_V3.pdf

English (722.13 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable