Clinical trial NCT01303900: Cardiovascular Disease (CVD) in Haemophilia
Official title: Cardiovascular Disease in Adult Haemophilia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Cardiovascular Disease
Keywords: Haemophilia
Cardiovascular disease
Cardiovascular disease risk factors
Prospective
QRISK2
Hypertension
Hypercholesterolaemia
Diabetes
Obesity
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 750
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ischemic cardiovascular disease
timeFrame: After 5 and 10 years
measure: Cardiovascular disease risk factors
timeFrame: At baseline
Secondary outcomes:
measure: Association between clotting factor concentrate administration and cardiovascular events
timeFrame: 5-10 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: Van Creveldkliniek, University Medical Center Utrecht
city: Cardiff
country: United Kingdom
facility: School of Medicine, Cardiff University and University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Glasgow Haemophilia and Thrombosis Centre, Royal Infirmary
city: London
country: United Kingdom
facility: Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital
Study officials:
References:
citation: 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.