- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303900
Cardiovascular Disease (CVD) in Haemophilia
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Groningen, Netherlands
- Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen
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Utrecht, Netherlands
- Van Creveldkliniek, University Medical Center Utrecht
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Cardiff, United Kingdom
- School of Medicine, Cardiff University and University Hospital of Wales
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Glasgow, United Kingdom
- Glasgow Haemophilia and Thrombosis Centre, Royal Infirmary
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London, United Kingdom
- Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
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Sheffield, United Kingdom
- Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Ischemic cardiovascular disease
Time Frame: After 5 and 10 years
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After 5 and 10 years
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Cardiovascular disease risk factors
Time Frame: At baseline
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Association between clotting factor concentrate administration and cardiovascular events
Time Frame: 5-10 years
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5-10 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVD study 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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