Aortic Valve Disease
Conditions
Keywords
AVD
Brief summary
Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment. In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.
Detailed description
The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when using: 1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3 2. 5000 IU/d Vitamin D3 as a control group
Interventions
DIETARY_SUPPLEMENTVitamin K2 (Menaquinone 7) + Vitamin D3
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
Sponsors
Omicron Pharmaceuticals
Nattopharma ASA
Hopital St. Georges, Ajaltoun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* AVCS \> 300 without aortic valve stenosis requiring operation * Focus on patients with: 1. Bicuspid aortic valve 2. Dialysis or CKD 3. Statin treatment
Exclusion criteria
* Use of Vitamin K antagonist * Malabsorption Problem * LVEF \< 40% * A life expectancy \< 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg) | 3 years |
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2) | 3 years |
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec) | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the Aortic Valve calcification measured by CT Scan | 3 years | Reduction of the Aortic Valve Calcification Score (AVCS) |
| Improvement of the quality of life of the patients | 3 years | Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 |
| Improvement of dyspnea (at rest and effort) | 3 years | Improvement of dyspnea according to the New York Heart Association Classification(NYHA) |
| Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification. | 3 years | 1. Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l) 2. Reduction of the Aortic Valve Calcification Score(AVCS) 3. Improvement of dyspnea according to the New York Heart Association Classification(NYHA) 4. Improvement of the quality of life of the patients( physical activity, mobility) |
Countries
Lebanon
Contacts
Primary ContactRodoplh Frangi, MD
Outcome results
None listed