Atrial Fibrillation, Heart Valve Prosthesis, Pulmonary Embolism, Venous Thrombosis
Conditions
Keywords
warfarin, genotyping, vitamin K, dosing, adverse events, initial phase of treatment, algorithm
Brief summary
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.
Interventions
OTHERBlood specimens (whole blood, serum, plasma)
The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.
Sponsors
University of Oslo
Norwegian Medicines Agency
Norway: South-Eastern Norway Regional Health Authority
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Caucasian * \>18 years of age * included in the study at the onset of warfarin treatment * target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves) * standard indications for warfarin treatment
Exclusion criteria
* Non-caucasian * Clinical significant liver affection * Heart failure, NYHA class III-IV * Non-compliant - not able to accomplish protocol demands * Not able to give informed consent * Long-term antibiotic therapy * Malabsorption conditions and inflammatory bowel disease
Countries
Norway
Outcome results
None listed