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| Name | Class |
|---|---|
| ClinStat GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VKA - Vitamin K antagonist group | VKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country. | ||
| Rivaroxaban group | Rivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country. | ||
| noAC group | noAC used in correspondence with the national guidelines for therapy of NVAF in the respective country. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| initiation of chronic renal replacement therapy | 12 month | |
| eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis) | 12 month | |
| eGFR decline of ≥ 30% |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CKD (eGFR15-49 mL/min per 1.73 m2) and NVAF are in the focus of the XARENO registry
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| Name | Affiliation | Role |
|---|---|---|
| Reinhold Kreutz, Prof. Dr. | Charite University, Berlin, Germany | Study Director |
| Jan Beyer-Westendorf, PD Dr. | University Clinic Technical University Dresden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus St. Josef Braunau | Braunau am Inn | 5280 | Austria | |||
| Medizinische Universitätsklinik |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 20, 2023 | |
| Reset | Nov 24, 2023 |
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| 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 |
| causes of hospitalizations | 12 month, 18 month |
| persistence with OAC therapy | 12 month, 18 month |
| reasons for OAC therapy discontinuation | descriptive analysis of reasons for therapy discontinuation (verbal description by investigator) | 12 month, 18 month |
| Graz |
| 8036 |
| Austria |
| Allgemeines Krankenhaus der STadt Linz | Linz | 4020 | Austria |
| Krankenhaus der Elisabethinen Linz | Linz | 4020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Meidzinische Universität Wien | Vienna | 1090 | Austria |
| Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital | Vienna | 1100 | Austria |
| Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel | Vienna | 1130 | Austria |
| Centre Hospitalier EpiCURA-Baudour | Baudour | Belgium |
| CUB Hôpital ERASME | Brussels | Belgium |
| CHU de Charleroi | Charleroi | 6000 | Belgium |
| Centre Hospitalier Régional de la Citadelle | Liège | 4000 | Belgium |
| Centre Hospitalier Chrétien (CHC) St Joseph | Liège | Belgium |
| Centre Hospitalier Régional de la Citadelle | Liège | Belgium |
| Centre Hospitalier Universiatire du SART-TILMAN | Liège | Belgium |
| Centre Hospitalier de Wallonie Picarde (Chwapi) | Tournai | Belgium |
| Clinique Sainte-Isabelle | Abbeville | 80100 | France |
| CH Abbeville | Abbeville | 80142 | France |
| CHU Amiens | Amiens | 80054 | France |
| CHU Angers | Angers | 49933 | France |
| CHU Angers | Angers | France |
| CH Argenteuil Centre Hospitalier Victor Dupouy | Argenteuil | 95107 | France |
| CHU Avicenne (AP-HP) | Bobigny | France |
| CHU Bordeaux-Hôpital Saint André | Bordeaux | 33075 | France |
| CHU Bordeaux-Hôpital Pellegrin | Bordeaux | 33076 | France |
| CHRU Brest-Hôpital la Cavale Blanche | Brest | France |
| CH Cholet | Cholet | 49300 | France |
| CHU Clermont Ferrand | Clermont-Ferrand | 63000 | France |
| Hôpital Louis Mourier (AP-HP) | Colombes | 92700 | France |
| CH de Compiègne-Noyon (CHNC) | Compiègne | 60200 | France |
| Hôpital Henri Mondor (AP-HP) | Créteil | 94010 | France |
| CHD Vendée | La Roche-sur-Yon | France |
| CHG de Chartres-Hôpital Général Louis Pasteur | Le Coudray | 28630 | France |
| CHR Metz-Thionville, Hôpital de Mercy | Metz | France |
| CHU Nantes-site Hotel Dieu | Nantes | 44093 | France |
| CHU Carémeau | Nîmes | 30000 | France |
| Pitié-Salpètrière Hospital (AP-HP) | Paris | 75013 | France |
| Claude Bernard - Bichat Hospital | Paris | 75018 | France |
| Hôpital Bretonneau (AP-HP) | Paris | 75018 | France |
| CHU Nantes-Hôpital nord Laennec | Saint-Herblain | 44800 | France |
| CHRU Strasbourg Nouvel Hôpital Civil | Strasbourg | 67000 | France |
| CHI Toulon La Seyne sur mer - Hopital Sainte Musse | Toulon | 83056 | France |
| Hôpital Nord Franche Comté | Trévenans | France |
| Kardiologische Praxis | Bad Homburg | Germany |
| Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin | Bensheim | 64625 | Germany |
| FA für Innere Medizin | Bergisch Gladbach | 51429 | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Vivantes Klinikum im Friedrichshain | Berlin | 10405 | Germany |
| Franziskus-Krankenhaus Berlin | Berlin | 10787 | Germany |
| Praxis Rankestrasse | Berlin | 10789 | Germany |
| MVZ Dres. Ramdohr | Berlin | 12043 | Germany |
| St. Joseph Krankenhaus Berlin-Tempelhof GmbH | Berlin | 12101 | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 12200 | Germany |
| Facharzt für Allgemeinmedizin | Berlin | 12459 | Germany |
| Praxis | Berlin | 13189 | Germany |
| Kardiologische Arztpraxis | Borsdorf | 04451 | Germany |
| Studienzentrum Schwittay | Böhlen | 04564 | Germany |
| Städtisches Klinikum Braunschweig gGmbH | Braunschweig | 38126 | Germany |
| Krankenhaus Buchholz | Buchholz | 21244 | Germany |
| Gemeinschaftspraxis Kellner und Ehrhardt | Camburg | 07774 | Germany |
| Klinikum Coburg GmbH | Coburg | 96450 | Germany |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Kardiologische Partnerschaftsgesellschaft | Cottbus | 03046 | Germany |
| ZID- Zentrum für Innere Medizin Dachau | Dachau | 85221 | Germany |
| Kardiovaskuläres Zentrum Darmstadt | Darmstadt | 64287 | Germany |
| Klinikum Dortmund GmbH | Dortmund | 44137 | Germany |
| Kardiologie Dortmund | Dortmund | 44141 | Germany |
| Nephrologische Praxis | Dortmund | 44263 | Germany |
| Praxisklinik Herzkreislauf am Wasaplatz | Dresden | 01219 | Germany |
| Praxis Dr. med Steffen Fischer | Dresden | 01277 | Germany |
| Praxis Dr. med. Christoph Axthelm & Kollegen | Dresden | 01277 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Gemeinschaftspraxis Dr. med. Sybille Jänsch | Dresden | 01309 | Germany |
| Praxis Dr. med. Frank Richard | Erfurt | 99084 | Germany |
| Klinikum Esslingen GmbH | Esslingen am Neckar | 73730 | Germany |
| Gemeinschaftspraxis im Altstadtcarree, Kardiologie | Fulda | 36037 | Germany |
| MVZ Prof. Mathey, Prof. Schofer GmbH | Hamburg | 22527 | Germany |
| Herzpraxis Altona | Hamburg | 22765 | Germany |
| Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen | Hanover | 30625 | Germany |
| DOKUSAN | Herne | 44623 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Praxisnetz Dr. Haaß & Kollegen | Inden | 52459 | Germany |
| Westpfalz-Klinikum GmbH | Kaiserslautern | 67655 | Germany |
| Studienzentrum Dr. med. Karl-Friedrich Appel | Kassel | 34121 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Gemeinschaftspraxis Wittwer, Bargemann, Baar | Kiel | 24116 | Germany |
| Gemeinschaftspraxis Scheuermann & Persicke | Kornwestheim | 70806 | Germany |
| Praxis | Königsbrück | 01936 | Germany |
| Eickenhof Dialyse - Gemeinschaftspraxis | Langenhagen | 30851 | Germany |
| Klinikum St. Georg GmbH | Leipzig | 04129 | Germany |
| Klinikum Leverkusen | Leverkusen | 51375 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Marburg | Marburg | 35033 | Germany |
| Praxis Dr. med. Jens Taggeselle | Markkleeberg | 04416 | Germany |
| Internistisches Facharztzentrum | Memmingen | 87700 | Germany |
| Herz-Gefäß-Zentrum Nymphenburg | München | 80638 | Germany |
| Marienkrankenhaus Klinikum St. Elisabeth | Neuwied | 56564 | Germany |
| Kardiologische Gemeinschaftspraxis | Nienburg | 31582 | Germany |
| Kardiologie am Weißen Turm | Nuremberg | 90402 | Germany |
| Praxis für Innere Medizin | Nuremberg | 90449 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | 90471 | Germany |
| via medis Nierenzentrum Oldenburg MVZ | Oldenburg | 26127 | Germany |
| Fachärztin für Allgemeinmedizin | Osnabrück | 49074 | Germany |
| MVZ Birkenallee | Papenburg | 26871 | Germany |
| Internistische Gemeinschaftspraxis | Passau | 94032 | Germany |
| Cardiologicum Prina | Pirna | 01796 | Germany |
| Praxis Dr. med. Christoph Axthelm & Kollegen | Pirna | 01796 | Germany |
| Paracelsus-Harz-Klinik | Quedlinburg | 06485 | Germany |
| KardioPrax Remscheid | Remscheid | 42853 | Germany |
| Zentrum für Prävention und Rehabilitation | Siegen | 57072 | Germany |
| Studienzentrum der Herzklinik Ulm GbR | Ulm | 89077 | Germany |
| Internistische Praxis Vellmar | Vellmar | 34246 | Germany |
| Schwarzwald-Baar-Klinikum | Villingen-Schwenningen | 78052 | Germany |
| Gemeinschaftspraxis Drs. Grosskopf | Wallerfing | 94574 | Germany |
| Kliniken Nordoberpfalz AG | Weiden | 92637 | Germany |
| Praxis Dr. med. Jörg Brosche | Weinböhla | 01689 | Germany |
| Kardiologische Praxis Dr. med. Ayham Al Zoebi | Wermsdorf | 04779 | Germany |
| Ev. Krankenhaus Witten gGmbH | Witten | 58455 | Germany |
| Kantonsspital Aarau AG | Aarau | 5001 | Switzerland |
| Kantonsspital Baden AG | Baden | 5404 | Switzerland |
| Klinik Hirslanden | Zurich | 8032 | Switzerland |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2023 | Nov 24, 2023 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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