Thilo Krueger1, Georg Schlieper1, Leon Schurgers2, Tom Cornelis3, Mario Cozzolino4, Johannes Jacobi5, Michel Jadoul6, Markus Ketteler7, Lars C Rump8, Peter Stenvinkel9, Ralf Westenfeld10, Andrzej Wiecek11, Sebastian Reinartz12, Ralf-Dieter Hilgers13, Jürgen Floege1. 1. Department of Nephrology and Immunology, Uniklinik RWTH Aachen, Aachen, Germany. 2. Cardiovascular Research Institute Maastricht (CARIM), University of Maastricht, Maastricht, The Netherlands. 3. Department of Internal Medicine, Division of Nephrology, Maastricht University Medical Center, Maastricht, The Netherlands. 4. Renal Division, University of Milan, Milan, Italy. 5. Department of Nephrology and Hypertension, University of Erlangen-Nuremberg, Erlangen, Germany. 6. Division of Nephrology, Cliniques universitaires Saint-Luc Université catholique de Louvain, Brussels, Belgium. 7. Department of Nephrology, Klinikum Coburg, Coburg, Germany. 8. Department of Nephrology, University Hospital of Duesseldorf, Germany. 9. Department of Renal Medicine, Karolinska University Hospital at Huddinge, Stockholm, Sweden. 10. Department of Cardiology, University Hospital of Duesseldorf, Duesseldorf, Germany. 11. Department of Nephrology, Endocrinology and Metabolic Diseases, Medical University of Silesia, Katowice, Poland. 12. Department of Radiology, Uniklinik RWTH Aachen, Aachen, Germany. 13. Institute of Medical Statistics, RWTH University Aachen, Aachen, Germany.
Abstract
BACKGROUND: Patients on haemodialysis (HD) exhibit increased cardiovascular mortality associated with accelerated vascular calcification (VC). VC is influenced by inhibitors such as matrix Gla protein (MGP), a protein activated in the presence of vitamin K. HD patients exhibit marked vitamin K deficiency, and supplementation with vitamin K reduces inactive MGP levels in these patients. The VitaVasK trial analyses whether vitamin K1 supplementation affects the progression of coronary and aortic calcification in HD patients. METHODS: VitaVasK is a prospective, randomized, parallel group, multicentre trial (EudraCT No.: 2010-021264-14) that will include 348 HD patients in an open-label, two-arm design. After baseline multi-slice computed tomography (MSCT) of the heart and thoracic aorta, patients with a coronary calcification volume score of at least 100 will be randomized to continue on standard care or to receive additional supplementation with 5 mg vitamin K1 orally thrice weekly. Treatment duration will be 18 months, and MSCT scans will be repeated after 12 and 18 months. Primary end points are the progression of thoracic aortic and coronary artery calcification (calculated as absolute changes in the volume scores at the 18-month MSCT versus the baseline MSCT). Secondary end points comprise changes in Agatston score, mitral and aortic valve calcification as well as major adverse cardiovascular events (MACE) and all-cause mortality. VitaVask also aims to record MACE and all-cause mortality in the follow-up period at 3 and 5 years after treatment initiation. This trial may lead to the identification of an inexpensive and safe treatment or prophylaxis of VC in HD patients.
RCT Entities:
BACKGROUND:Patients on haemodialysis (HD) exhibit increased cardiovascular mortality associated with accelerated vascular calcification (VC). VC is influenced by inhibitors such as matrix Gla protein (MGP), a protein activated in the presence of vitamin K. HDpatients exhibit marked vitamin K deficiency, and supplementation with vitamin K reduces inactive MGP levels in these patients. The VitaVasK trial analyses whether vitamin K1 supplementation affects the progression of coronary and aortic calcification in HDpatients. METHODS: VitaVasK is a prospective, randomized, parallel group, multicentre trial (EudraCT No.: 2010-021264-14) that will include 348 HDpatients in an open-label, two-arm design. After baseline multi-slice computed tomography (MSCT) of the heart and thoracic aorta, patients with a coronary calcification volume score of at least 100 will be randomized to continue on standard care or to receive additional supplementation with 5 mg vitamin K1 orally thrice weekly. Treatment duration will be 18 months, and MSCT scans will be repeated after 12 and 18 months. Primary end points are the progression of thoracic aortic and coronary artery calcification (calculated as absolute changes in the volume scores at the 18-month MSCT versus the baseline MSCT). Secondary end points comprise changes in Agatston score, mitral and aortic valve calcification as well as major adverse cardiovascular events (MACE) and all-cause mortality. VitaVask also aims to record MACE and all-cause mortality in the follow-up period at 3 and 5 years after treatment initiation. This trial may lead to the identification of an inexpensive and safe treatment or prophylaxis of VC in HDpatients.
Authors: Kana N Miyata; Cynthia C Nast; Tiane Dai; Ramanath Dukkipati; Janine A LaPage; Jonathan P Troost; Leon J Schurgers; Matthias Kretzler; Sharon G Adler Journal: Exp Mol Pathol Date: 2018-07-06 Impact factor: 3.362
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Authors: Szabolcs Péter; Gerjan Navis; Martin H de Borst; Clemens von Schacky; Anne Claire B van Orten-Luiten; Alexandra Zhernakova; Renger F Witkamp; André Janse; Peter Weber; Stephan J L Bakker; Manfred Eggersdorfer Journal: Eur J Nutr Date: 2017-08 Impact factor: 5.614