The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 试验地点
- 2
- 主要终点
- Aortic valve calcification
研究概览
简要总结
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). The investigators hypothesize that MK-7 supplementation will slow down the calcification process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization-list is available to the data and safety monitoring board, but patients, nurses, physicians and other data collectors are kept blinded to the allocation during the study.
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants in the Danish Cardiovascular Screening Trial (Trials. 2015 Dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible.
排除标准
- •Known aortic valve disease (peak velocity ≥3.0 m/s)
- •History of venous thrombosis or other coagulation disorders or use of vitamin K antagonists
- •Disorders of calcium and phosphate metabolism
- •A life-expectancy < 5 years
结局指标
主要结局
Aortic valve calcification
时间窗: From baseline to two years of follow-up
The primary endpoint is the change in aortic valve calcification. The natural history of the aortic valve calcification is not adequately understood, and accordingly the changes are analyzed in two prespecified patient subgroups (AVC score 300-599 and ≥600, respectively).
次要结局
- Quality of life(From baseline to two years of follow-up)
- Coronary plaque composition(From baseline to two years of follow-up)
- Aortic valve area(From baseline to two years of follow-up)
- Bone mineral density(From baseline to two years of follow-up)
- Arterial calcification(From baseline to two years of follow-up)
- Aortic size(From baseline to two years of follow-up)
- Biomarkers of calcification(From baseline to two years of follow-up)
研究者
Axel Diederichsen
Associated professor
Odense University Hospital