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Medial arterial calcification in patients with haemophilia


- candidate number22527
- NTR NumberNTR5284
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2015
- Secondary IDsNL51599.042.14 ABR nummer
- Public TitleMedial arterial calcification in patients with haemophilia
- Scientific TitleMedial arterial calcification in patients with haemophilia
- ACRONYMMIRACLE
- hypothesisIn hemophilia patients arterial hypertension is more common than in de general population. The cause of this increased prevalence is unknown. Recent studies on atherosclerosis in hemophilia focused on intima lesions. However, arterial calcification may affect the media as well. Medial arterial calcification (MAC) leads to concentric media thickening and stiffening of the arterial wall. Since arterial stiffness is an important contributor to arterial hypertension, MAC and consequently arterial stiffness may be more prevalent in hemophiliacs, and this may explain the high rate of systolic hypertension. MAC can be detected by measurement of the ankle brachial index. There are no reports on MAC in hemophilia.
- Healt Condition(s) or Problem(s) studiedHaemophilia, Vascular calcification, Ankle brachial index
- Inclusion criteria- Hemophilia A or B
- Males, adults
-Written informed consent for study participation
- Exclusion criteria- History of peripheral artery occlusive disease.
- History of ESRD , defined as eGFR < 60 ml/ min, calculated according to the Modification of Diet in Renal Disease formula.
- History of Diabetes Mellitus.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2015
- planned closingdate1-aug-2016
- Target number of participants50
- InterventionsSingle measurement of ankel brachial index and toe brachial index.
- Primary outcomeAnkel brachial index
Toe brachial index
- Secondary outcome- Blood pressure, weight, height, waist circumference
- Data related to cardiovascular risk factors will be obtained by a standardised questionnaire.
- Severity of haemophilia, bleeding events.
-Total cholesterol, LDL-, and HDL- cholesterol, triglycerides, glucose, HbA1c, creatinine, alkaline phosphatase, calcium, phosphate, albumin.
- Timepointssingle visit
- Trial web siten.a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESarts-onderzoeker Hilde Hop
- CONTACT for SCIENTIFIC QUERIESarts-onderzoeker Hilde Hop
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-jul-2015 - 25-nov-2016


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