I48
Conditions
Interventions
Group 1: Treatment arm:
Naturalistic longitudinal examination of approximately 25 adult patients consecutively admitted at one year's hospital admission to the thrombus inhibitor dabigatran (Pradaxa®)
Additionally it is planned:
• creation of an ECG
with VHF also LZ-ECG
• Blood pressure measurement
• 6-minute walk test
• Assignment of the patient to a functional performance class (NYHA, EHRA, WHO)
• Acquiring echocardiography, if not collected an
Sponsors
Universitätsklinik für Kardiologie und Angiologie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Treatment group: Patients receiving dabigatran under one of the approved indications, e.g. non-valvular atrial fibrillation, thrombosis, pulmonary embolism or control group: Patients who, after clarifying questionable cardiac arrhythmias, do not require further drug or pacemaker treatment
Exclusion criteria
Exclusion criteria: a) contraindications for dabigatran, e.g. Hypersensitivity to the active substance or to any of the excipients, severe renal insufficiency (creatinine clearance [CrCl] <30 ml / min), acute clinically relevant bleeding, organ damage increasing the risk of bleeding, spontaneous or pharmacological limitation of haemostasis, severe liver disease, concomitant systemically administered ketoconazole, cyclosporin, itraconazole or tacrolimus; Pat. With artificial heart valves. b) Severe infections, trauma, tumors or terminal diseases that affect the brain. c) Lack of consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Treatment arm: Change in timidity under anticoagulant therapy: Hamilton anxiety scale / HAM-A - control group: Change in timidity under anticoagulant therapy: Hamilton anxiety scale / HAM-A -exploratory analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Altering Anxiety with Anticoagulant Therapy: State Trait Anger Expression Inventory / STAXI | — |
Countries
Germany
Contacts
Public ContactOliver Wolfram
Universitätsklinik für Kardiologie und Angiologie
Outcome results
None listed