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Cardiovascular Disease (CVD) in Haemophilia

NCT ID: NCT01303900

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Brief Summary

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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

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Conditions

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Haemophilia Cardiovascular Disease

Keywords

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Haemophilia Cardiovascular disease Cardiovascular disease risk factors Prospective QRISK2 Hypertension Hypercholesterolaemia Diabetes Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Haemophilia A or B (mild, moderate or severe)
* Male gender
* Age 30 years or older
* Treated at participating haemophilia treatment center
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Van Creveldkliniek, UMC Utrecht

Locations

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Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen

Groningen, , Netherlands

Site Status

Van Creveldkliniek, University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

School of Medicine, Cardiff University and University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Glasgow Haemophilia and Thrombosis Centre, Royal Infirmary

Glasgow, , United Kingdom

Site Status

Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital

London, , United Kingdom

Site Status

Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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Van Der Valk P, Makris M, Fischer K, Tait RC, Chowdary P, Collins PW, Meijer K, van Vulpen LFD, Mauser-Bunschoten E, Schutgens REG. Reduced cardiovascular morbidity in patients with hemophilia: results of a 5-year multinational prospective study. Blood Adv. 2022 Feb 8;6(3):902-908. doi: 10.1182/bloodadvances.2021005260.

Reference Type DERIVED
PMID: 34879394 (View on PubMed)

Other Identifiers

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CVD study 1

Identifier Type: -

Identifier Source: org_study_id