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| Name | Class |
|---|---|
| Omicron Pharmaceuticals | INDUSTRY |
| Nattopharma ASA | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Active Comparator | 1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve |
|
| interventional | Active Comparator | 5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 (Menaquinone 7) + Vitamin D3 | Dietary Supplement | Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification. |
|
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Inclusion Criteria:
AVCS > 300 without aortic valve stenosis requiring operation
Focus on patients with:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodoplh Frangi, MD | Contact | 00961 9 234 202 | 1100 | drfrangi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint-George Ajaltoun | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| C062629 | menaquinone 7 |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| 3 years |
| Reduction of the Aortic Valve calcification measured by CT Scan | Reduction of the Aortic Valve Calcification Score (AVCS) | 3 years |
| Improvement of dyspnea (at rest and effort) | Improvement of dyspnea according to the New York Heart Association Classification(NYHA) | 3 years |
| Improvement of the quality of life of the patients | Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 | 3 years |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |