Vitamin K1 to slow vascular calcification in hemodialysis patients (VitaVasK)
- Conditions
- vascular calcification1003843010014523
- Registration Number
- NL-OMON40146
- Lead Sponsor
- RWTH Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 80
Male or female * 18 years of age
Not less than 6 months on hemodialysis
Cardiovascular calcification present (coronary artery volume score > 100)
Written consent to take part in the study
Life expectancy not less than 18 months
Use of vitamin K
Known hypersensitivity against vitamin K1
History of thrombosis
Intake of vitamin K antagonists (e.g. Marcumar®) at baseline or in the 3 months prior to baseline
Inflammatory bowel disease
Short-bowel syndrome
Significant liver dysfunction
Coronary stent
Hemoglobin < 70 g/L
Women who are pregnant or breastfeeding
Women without sufficient contraception
Alcohol or drug abuse
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up-visits and unlikelihood of completing the study
Participation in a parallel clinical trial or participation in another clinical trial within the previous 3 months
Subjects who are in any state of dependency to the sponsor or the investigators
Employees of the sponsor or the investigators
Subjects who have been committed to an institution by legal or regulatory order
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints of this study are<br /><br>1. Progression of thoracic aortic calcification (absolute change of the volume<br /><br>score at the 18-month (defined as 18 months +/- 4 weeks) MSCT versus the<br /><br>baseline MSCT),<br /><br>2. Progression of coronary artery calcification (absolute change of the volume<br /><br>score at the 18-month MSCT versus the baseline MSCT).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of this study are<br /><br>1. Progression of thoracic aortic calcification (absolute change of the<br /><br>Agatston score at the 18-month MSCT versus the baseline MSCT),<br /><br>2. Progression of coronary artery calcification (absolute change of the<br /><br>Agatston score at the 18-month MSCT versus the baseline MSCT),<br /><br>3. Progression of aortic valve calcification (absolute change of the Agatston<br /><br>and volume scores at the 18-month MSCT versus the baseline MSCT),<br /><br>4. Progression of mitral valve calcification (absolute change of the Agatston<br /><br>and volume scores at the 18-month MSCT versus the baseline MSCT),<br /><br>5. Mortality from any cause within 18 months after starting the treatment,<br /><br>6. Major adverse cardiovascular events: myocardial infarction, stroke, acute<br /><br>coronary syndrome, embolism, symptom-driven revascularization, death from<br /><br>cardiovascular cause within 18 months after starting the treatment</p><br>