Cardiovascular Disease (CVD) in Haemophilia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01303900
First received: February 24, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303900

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
Sponsors and Collaborators
UMC Utrecht
  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 August 19, 2014