The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2). The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.
This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines. This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg. The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months). The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy. The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.
Study Type
OBSERVATIONAL
Enrollment
1,700
decline in eGFR in mL/min per 1.73 m2
Time frame: 12 month
major bleeding
Time frame: 12 month
all-cause mortality
Time frame: 12 month
TIA, stroke or systemic arterial embolism
Time frame: 12 month
major cardiovascular events (MACE)
Time frame: 12 month
symptomatic venous thromboembolic events
Time frame: 12 month
net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)
Time frame: 12 month
initiation of chronic renal replacement therapy
Time frame: 12 month
eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)
Time frame: 12 month
eGFR decline of ≥ 30%
Time frame: 12 month
doubling of serum creatine concentration
Time frame: 12 month
acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis
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Krankenhaus St. Josef Braunau
Braunau am Inn, Austria
Medizinische Universitätsklinik
Graz, Austria
Allgemeines Krankenhaus der STadt Linz
Linz, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
Medizinische Universität Wien
Vienna, Austria
Meidzinische Universität Wien
Vienna, Austria
Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
Vienna, Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, Austria
Centre Hospitalier EpiCURA-Baudour
Baudour, Belgium
CUB Hôpital ERASME
Brussels, Belgium
...and 111 more locations
Time frame: 12 month, 18 month
rates of hospitalizations
Time frame: 12 month, 18 month
length of hospitalizations
Time frame: 12 month, 18 month
causes of hospitalizations
Time frame: 12 month, 18 month
persistence with OAC therapy
Time frame: 12 month, 18 month
reasons for OAC therapy discontinuation
descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)
Time frame: 12 month, 18 month