Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialysis Patients: The iPACK-HD Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Compliance with study medication
研究概览
简要总结
The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
详细描述
At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification (VC) of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the three major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in prevalent hemodialysis patients with a baseline CAC score of ≥ 30 Agatston Units compared to placebo?
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide signed informed consent
- •≥18 years of age
- •Expected to survive one year
- •Have end-stage kidney disease and require hemodialysis
- •Have a baseline coronary artery calcification score ≥30 Agatston units (AUs)
排除标准
- •Have a medical condition that requires warfarin
- •Require hemodialysis for acute kidney injury
- •Are Pregnant
- •Have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year
- •Have undergone coronary artery bypass grafting or have stents placed in their coronary arteries
- •Are currently enrolled in another interventional trial
研究组 & 干预措施
Placebo
Microcrystalline Methylcellulose
干预措施: Microcrystalline Methylcellulose (Drug)
Vitamin K1
Vitamin K1
干预措施: Vitamin K1 (Drug)
结局指标
主要结局
Compliance with study medication
时间窗: 12 months
Proportion of prescribed doses received.
Dropout rate
时间窗: 12 months
Proportion of participants who dropped out from the trial.
Recruitment rate
时间窗: 12 months
Number of participants recruited per month at each site) and an overall crude average of each site's rate.
Rates of eligible patients consented and randomized
时间窗: 12 months
Proportion of eligible patients consented and randomized.
Adherence to study protocol
时间窗: 12 months
Proportion of participants who adhered to the study protocol.
次要结局
- Aortic valve calcification (Agatston calcium scores) progression(12 months)
- Coronary artery calcification (volume calcium scores) regression(12 months)
- Mitral valve calcification (Agatston calcium scores) progression(12 months)
- Mitral valve calcification (volume calcium scores) progression(12 months)
- Coronary artery calcification (volume calcium scores) progression(12 months)
- Aortic valve calcification (volume calcium scores) progression(12 months)
- Levels of biomarkers of vitamin K status(12 months)
- Coronary artery calcification (Agatston calcium scores) progression(12 months)
- Coronary artery calcification (Agatston calcium scores) regression(12 months)
- Prevalence and incidence of lumbar vertebral fractures(12 months)
- Presence/absence and total thrombotic events(12 months)
- Abdominal aortic calcification (AAC) scores(12 months)
- Presence/absence and total hospitalizations(12 months)
- Presence/absence and total cardiovascular events(12 months)
- Prevalence and incidence of thoracic vertebral fractures(12 months)
- Presence/absence and total hemodialysis access thrombotic events(12 months)
- Presence/absence and total mortality(12 months)
研究者
Dr. Rachel Holden
Professor of Medicine Queen's University
Clinical Evaluation Research Unit at Kingston General Hospital