|- candidate number||22527|
|- NTR Number||NTR5284|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2015|
|- Secondary IDs||NL51599.042.14 ABR nummer|
|- Public Title||Medial arterial calcification in patients with haemophilia
|- Scientific Title||Medial arterial calcification in patients with haemophilia
|- hypothesis||In 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) studied||Haemophilia, 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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2015|
|- planned closingdate||1-aug-2016|
|- Target number of participants||50|
|- Interventions||Single measurement of ankel brachial index and toe brachial index. |
|- Primary outcome||Ankel 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.
|- Timepoints||single visit|
|- Trial web site||n.a|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hilde Hop|
|- CONTACT for SCIENTIFIC QUERIES|| Hilde Hop|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||31-jul-2015 - 25-nov-2016|