Cardiovascular Disease (CVD) in Haemophilia
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Purpose
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 |
|---|
|
Haemophilia Cardiovascular Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cardiovascular Disease in Adult Haemophilia Patients |
- 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 ]
- Association between clotting factor concentrate administration and cardiovascular events [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | January 2009 |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| 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.
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| Netherlands | |
| Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen | |
| Groningen, Netherlands | |
| Van Creveldkliniek, University Medical Center Utrecht | |
| Utrecht, Netherlands | |
| 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, United Kingdom | |
More Information
No publications provided
| Responsible Party: | Dr. E.P. Mauser-Bunschoten, Van Creveldkliniek, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01303900 History of Changes |
| Other Study ID Numbers: | CVD study 1 |
| Study First Received: | February 24, 2011 |
| Last Updated: | February 24, 2011 |
| Health Authority: | The Netherlands: Medical Ethics Revieuw Board UMC Utrecht |
Keywords provided by UMC Utrecht:
|
Haemophilia Cardiovascular disease Cardiovascular disease risk factors Prospective QRISK2 |
Hypertension Hypercholesterolaemia Diabetes Obesity |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders |
Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 19, 2013