Cardiovascular Disease (CVD) in Haemophilia

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

UMC Utrecht

ClinicalTrials.gov Identifier:

NCT01303900

First received: February 24, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 24, 2011
Last Updated Date	February 24, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2011)	Ischemic cardiovascular disease [ Time Frame: After 5 and 10 years ] [ Designated as safety issue: No ] Cardiovascular disease risk factors [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 24, 2011)	Association between clotting factor concentrate administration and cardiovascular events [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cardiovascular Disease (CVD) in Haemophilia
Official Title ^ICMJE	Cardiovascular Disease in Adult Haemophilia Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	All male haemophilia patients aged 30 years or older who are treated at one of the participating haemophilia treatment centers (Utrecht and Groningen, The Netherlands, and Sheffield, london, Cardiff and Glasgow, UK). Patients are recruited during regular clinic visits.
Condition ^ICMJE	Haemophilia Cardiovascular Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	750
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01303900
Other Study ID Numbers ^ICMJE	CVD study 1
Has Data Monitoring Committee	No
Responsible Party	Dr. E.P. Mauser-Bunschoten, Van Creveldkliniek, UMC Utrecht
Study Sponsor ^ICMJE	UMC Utrecht
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	UMC Utrecht
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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