TY - JOUR
T1 - Effects of menaquinone-7 supplementation in patients with aortic valve calcification
T2 - study protocol for a randomised controlled trial
AU - Lindholt, Jes Sanddal
AU - Frandsen, Niels Erik
AU - Fredgart, Maise Høigaard
AU - Øvrehus, Kristian A
AU - Dahl, Jordi Sanchez
AU - Møller, Jacob Eifer
AU - Folkestad, Lars
AU - Urbonaviciene, Grazina
AU - Becker, Søren Warberg
AU - Lambrechtsen, Jess
AU - Auscher, Søren
AU - Hosbond, Susanne
AU - Alan, Dilek Hunerel
AU - Rasmussen, Lars Melholt
AU - Gerke, Oke
AU - Mickley, Hans
AU - Diederichsen, Axel
N1 - © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - INTRODUCTION: Aortic stenosis is a common heart valve disease, and due to the growing elderly population, the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed; thus, presently, the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). We hypothesise that MK-7 supplementation will slow down the calcification process.METHODS AND ANALYSIS: In this multicenter and double-blinded, placebo-controlled study, 400 men aged 65-74 years with substantial AVC are randomised (1:1) to treatment with MK-7 (720 µg/day) supplemented by the recommended daily dose of vitamin D (25 µg/day) or placebo treatment (no active treatment) for 2 years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate AVC score, a non-contrast CT scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in AVC score from baseline to follow-up at 2 years. Intention-to-treat principle is used for all analyses.ETHICS AND DISSEMINATION: There are no reported adverse effects associated with the use of MK-7. The protocol is approved by the Regional Scientific Ethical Committee for Southern Denmark (S-20170059) and the Data Protection Agency (17/19010). It is conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.TRIAL REGISTRATION NUMBER: NCT03243890.
AB - INTRODUCTION: Aortic stenosis is a common heart valve disease, and due to the growing elderly population, the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed; thus, presently, the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). We hypothesise that MK-7 supplementation will slow down the calcification process.METHODS AND ANALYSIS: In this multicenter and double-blinded, placebo-controlled study, 400 men aged 65-74 years with substantial AVC are randomised (1:1) to treatment with MK-7 (720 µg/day) supplemented by the recommended daily dose of vitamin D (25 µg/day) or placebo treatment (no active treatment) for 2 years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate AVC score, a non-contrast CT scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in AVC score from baseline to follow-up at 2 years. Intention-to-treat principle is used for all analyses.ETHICS AND DISSEMINATION: There are no reported adverse effects associated with the use of MK-7. The protocol is approved by the Regional Scientific Ethical Committee for Southern Denmark (S-20170059) and the Data Protection Agency (17/19010). It is conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.TRIAL REGISTRATION NUMBER: NCT03243890.
KW - aortic valve calcification
KW - cardiovascular imaging
KW - menaquinone-7
KW - randomized clinical trial
KW - valvular heart disease
U2 - 10.1136/bmjopen-2018-022019
DO - 10.1136/bmjopen-2018-022019
M3 - Journal article
C2 - 30139903
VL - 8
JO - B M J Open
JF - B M J Open
SN - 2044-6055
IS - 8
M1 - e022019
ER -