Chronic Kidney Disease (CKD), Non-valvular Atrial Fibrillation (NVAF)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
ClinStat GmbH
GWT-TUD GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female patients, age ≥ 18 years * CKD with eGFR 15 - 49 mL/min per 1.73 m2 * non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy * a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort) * informed consent * availability for follow up * life expectancy of ≥6 months
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| decline in eGFR in mL/min per 1.73 m2 | 12 month |
| major bleeding | 12 month |
| all-cause mortality | 12 month |
| TIA, stroke or systemic arterial embolism | 12 month |
| major cardiovascular events (MACE) | 12 month |
| symptomatic venous thromboembolic events | 12 month |
| net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality) | 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| causes of hospitalizations | 12 month, 18 month | — |
| initiation of chronic renal replacement therapy | 12 month | — |
| reasons for OAC therapy discontinuation | 12 month, 18 month | descriptive analysis of reasons for therapy discontinuation (verbal description by investigator) |
| persistence with OAC therapy | 12 month, 18 month | — |
| eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis) | 12 month | — |
| eGFR decline of ≥ 30% | 12 month | — |
| doubling of serum creatine concentration | 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 | 12 month, 18 month | — |
| rates of hospitalizations | 12 month, 18 month | — |
| length of hospitalizations | 12 month, 18 month | — |
Countries
Austria, Belgium, France, Germany, Switzerland
Outcome results
None listed