Cardiovascular Disease (CVD) in Haemophilia

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT01303900

Collaborator

(none)

750

Enrollment

Locations

125

Patients Per Site

Study Details

Study Description

Brief Summary

Life expectancy of hemophilia patients has improved considerably during the past decades and is approaching that of the general population. Hemophilia patients are therefore likely to be confronted with age-related disorders in addition to their primary illness and related diseases. Little is known about the occurrence of age-related co-morbidity, especially cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk factors has been made so far.

The aim of our study is to assess the occurrence of CVD and its risk factors in a large cohort of haemophilia patients.

In this prospective multicenter cohort study in a group of 700-800 male patients with haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD history and CVD risk factors will be collected at baseline and compared with the general age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and also compared with the general population. During a follow-up period of 5 and 10 years the occurrence of CVD events will be recorded and compared with the expected occurrence based on the QRISK2 scores and with data from the general population.

Condition or Disease	Intervention/Treatment	Phase
Haemophilia Cardiovascular Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiovascular Disease in Adult Haemophilia Patients

Study Start Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

Ischemic cardiovascular disease [After 5 and 10 years]
Cardiovascular disease risk factors [At baseline]

Secondary Outcome Measures

Association between clotting factor concentrate administration and cardiovascular events [5-10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Haemophilia A or B (mild, moderate or severe)
Male gender
Age 30 years or older
Treated at participating haemophilia treatment center

Exclusion Criteria:

No specific exclusion criteria

Contacts and Locations

Locations

	Site	City	Country
1	Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen	Groningen	Netherlands
2	Van Creveldkliniek, University Medical Center Utrecht	Utrecht	Netherlands
3	School of Medicine, Cardiff University and University Hospital of Wales	Cardiff	United Kingdom
4	Glasgow Haemophilia and Thrombosis Centre, Royal Infirmary	Glasgow	United Kingdom
5	Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital	London	United Kingdom
6	Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital	Sheffield	United Kingdom