HaemophiliaNCT01303900
Cardiovascular Disease (CVD) in Haemophilia
An observational study of Haemophilia and Cardiovascular Disease, run by UMC Utrecht at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Haemophilia, Cardiovascular Disease
- How many people
- 750 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Haemophilia A or B (mild, moderate or severe)
- Male gender
- Age 30 years or older
- Treated at participating haemophilia treatment center
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom4 sites
School of Medicine, Cardiff University and University Hospital of Wales
Cardiff
Glasgow Haemophilia and Thrombosis Centre, Royal Infirmary
Glasgow
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
London
Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital
Sheffield
Netherlands2 sites
Division of Haemostasis and Thrombosis, Department of Haematology, University Medical Center Groningen
Groningen
Van Creveldkliniek, University Medical Center Utrecht
Utrecht
About this study
Official title: 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.
- Conditions
- Haemophilia, Cardiovascular Disease
- Keywords
- Haemophilia, Cardiovascular disease, Cardiovascular disease risk factors, Prospective, QRISK2, Hypertension, Hypercholesterolaemia, Diabetes, Obesity
- Medical subject headings
- Hemophilia A, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic cardiovascular disease
Measured: After 5 and 10 years
Cardiovascular disease risk factors
Measured: At baseline
Secondary outcomes (1)
Association between clotting factor concentrate administration and cardiovascular events
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303900
- Sponsor's protocol ID
- CVD study 1
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34879394
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease in Adult Haemophilia Patients
- ClinicalTrials.gov ID
- NCT01303900
- Acronym / sponsor ID
- CVD study 1
- Conditions
- Haemophilia, Cardiovascular Disease
- Keywords
- Haemophilia, Cardiovascular disease, Cardiovascular disease risk factors, Prospective, QRISK2, Hypertension, Hypercholesterolaemia, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Haemophilia A or B (mild, moderate or severe)
- Male gender
- Age 30 years or older
- Treated at participating haemophilia treatment center
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ischemic cardiovascular disease
Time frame: After 5 and 10 years
Cardiovascular disease risk factors
Time frame: At baseline
1 secondary outcome
Association between clotting factor concentrate administration and cardiovascular events
Time frame: 5-10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
- Derived from this study: PubMed 34879394Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia and Cardiovascular Disease, run by UMC Utrecht at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic cardiovascular disease (time frame: After 5 and 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2011.