Effects of menaquinone-7 supplementation in patients with aortic valve calcification

study protocol for a randomised controlled trial

Jes Sanddal Lindholt, Niels Erik Frandsen, Maise Høigaard Fredgart, Kristian A Øvrehus, Jordi Sanchez Dahl, Jacob Eifer Møller, Lars Folkestad, Grazina Urbonaviciene, Søren Warberg Becker, Jess Lambrechtsen, Søren Auscher, Susanne Hosbond, Dilek Hunerel Alan, Lars Melholt Rasmussen, Oke Gerke, Hans Mickley, Axel Diederichsen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

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.

OriginalsprogEngelsk
Artikelnummere022019
TidsskriftBMJ Open
Vol/bind8
Udgave nummer8
Antal sider7
ISSN2044-6055
DOI
StatusUdgivet - 1. aug. 2018

Fingeraftryk

Randomized Controlled Trials
Helsinki Declaration
Placebos
Computer Security
Denmark
vitamin MK 7
Calcification of Aortic Valve
Population

Citer dette

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title = "Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial",
abstract = "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.",
keywords = "aortic valve calcification, cardiovascular imaging, menaquinone-7, randomized clinical trial, valvular heart disease",
author = "Lindholt, {Jes Sanddal} and Frandsen, {Niels Erik} and Fredgart, {Maise H{\o}igaard} and {\O}vrehus, {Kristian A} and Dahl, {Jordi Sanchez} and M{\o}ller, {Jacob Eifer} and Lars Folkestad and Grazina Urbonaviciene and Becker, {S{\o}ren Warberg} and Jess Lambrechtsen and S{\o}ren Auscher and Susanne Hosbond and Alan, {Dilek Hunerel} and Rasmussen, {Lars Melholt} and Oke Gerke and Hans Mickley and Axel Diederichsen",
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Effects of menaquinone-7 supplementation in patients with aortic valve calcification : study protocol for a randomised controlled trial. / Lindholt, Jes Sanddal; Frandsen, Niels Erik; Fredgart, Maise Høigaard; Øvrehus, Kristian A; Dahl, Jordi Sanchez; Møller, Jacob Eifer; Folkestad, Lars; Urbonaviciene, Grazina; Becker, Søren Warberg; Lambrechtsen, Jess; Auscher, Søren; Hosbond, Susanne; Alan, Dilek Hunerel; Rasmussen, Lars Melholt; Gerke, Oke; Mickley, Hans; Diederichsen, Axel.

I: BMJ Open, Bind 8, Nr. 8, e022019, 01.08.2018.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

VL - 8

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 8

M1 - e022019

ER -