Cardiovascular Disease (CVD) in Haemophilia

Cardiovascular Disease Clinical Trial

Official title:

Cardiovascular Disease in Adult Haemophilia Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01303900
• Other study ID #: CVD study 1
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 24, 2011
• Last updated: February 24, 2011
• Start date: January 2009

Study information

• Verified date: February 2011
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Medical Ethics Revieuw Board UMC Utrecht
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Haemophilia
• Hemophilia A

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic cardiovascular disease		After 5 and 10 years	No
Primary	Cardiovascular disease risk factors		At baseline	No
Secondary	Association between clotting factor concentrate administration and cardiovascular events		5-10 years	No