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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
| Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
| Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
| Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
| Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
| Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
| Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
| Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
| Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
| Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
| Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
| Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
| Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
| Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
| Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
| Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
| Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
| Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |