Cardiovascular Disease (CVD) in Haemophilia
|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
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||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|
|Brief Title ICMJE||Cardiovascular Disease (CVD) in Haemophilia|
|Official Title ICMJE||Cardiovascular Disease in Adult Haemophilia Patients|
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|
|Sampling Method||Non-Probability Sample|
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.
|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 Status ICMJE||Enrolling by invitation|
|Estimated Enrollment ICMJE||750|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|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|
|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