Cystic Fibrosis Clinical Trial
Official title:
Pilot Study to Assess the Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation
Background: Elastin is a unique protein providing elasticity, resilience and deformability to
dynamic tissues, such as lungs and vasculature. Elastin fibers are characterized by their
high affinity for calcium. However, calcified elastin is more prone to the degrading effects
of proteases and, in turn, partially degraded elastin has an even higher affinity for
calcium. A disturbed balance between proteases and anti-proteases is a major underlying
mechanism in the development of chronic obstructive pulmonary disease (COPD). Virtually the
only protein that can protect elastin from calcification is matrix Gla-protein (MGP), which
needs vitamin K for its activation. In COPD patients, a lower vitamin K status is found when
compared to control subjects and an inverse association exists between vitamin K status and
elastin degradation. In addition, vitamin K status is lower and elastin degradation is
accelerated in Vitamin K antagonist (VKA) users.
VKAs are widely used. Nowadays, an increasing number of patients uses direct oral
anticoagulants (DOACs), which do not influence vitamin K status. The hypothesis of this study
is that discontinuation of VKAs results in an improved vitamin K status and deceleration of
elastin degradation. In order to test this hypothesis, an observational pilot study will be
conducted in which the change in elastin degradation- quantified by plasma desmosine
concentrations - in patients who discontinue use of VKAs will be used as primary endpoint.
Study design: Observational study. Study population: A total of 30 VKA users who will
discontinue the use of VKAs. Elastin degradation rate (quantified by plasma desmosine levels)
and vitamin K status (quantified by measuring plasma levels of dephosphorylated
uncarboxylated (dp-uc)MGP) will be measured during the use of VKAs and approximately 6 months
after discontinuation of VKAs. Furthermore, the VKORC1 polymorphisms will be determined.
Main study parameters: The primary endpoint is the change in the rate of elastin degradation
quantified by the plasma desmosine assay. Secondary endpoints are the change in vitamin K
status quantified by measuring plasma levels of dp-ucMGP, the relation between desmosine and
dp-ucMGP and differences of desmosine and dp-ucMGP levels among subjects with different
polymorphisms of the vitamin K 2,3-epoxide reductase complex 1 (VKORC1) gene.
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