- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305536
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7) (DECAV-K2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
- 5000 IU/d Vitamin D3 as a control group
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Rodoplh Frangi, MD
- Phone Number: 1100 00961 9 234 202
- Email: drfrangi@hotmail.com
Study Locations
-
-
-
Beirut, Lebanon
- Recruiting
- Hopital Saint-George Ajaltoun
-
Contact:
- Rodolphe Frangi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AVCS > 300 without aortic valve stenosis requiring operation
Focus on patients with:
- Bicuspid aortic valve
- Dialysis or CKD
- Statin treatment
Exclusion Criteria:
- Use of Vitamin K antagonist
- Malabsorption Problem
- LVEF < 40%
- A life expectancy < 3 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interventional
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
|
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
Other Names:
|
Active Comparator: interventional
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
|
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Time Frame: 3 years
|
3 years
|
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Time Frame: 3 years
|
3 years
|
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
Time Frame: 3 years
|
|
3 years
|
Reduction of the Aortic Valve calcification measured by CT Scan
Time Frame: 3 years
|
Reduction of the Aortic Valve Calcification Score (AVCS)
|
3 years
|
Improvement of dyspnea (at rest and effort)
Time Frame: 3 years
|
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
|
3 years
|
Improvement of the quality of life of the patients
Time Frame: 3 years
|
Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Valve Diseases
- Aortic Valve Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Bone Density Conservation Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin D
- Vitamin K
- Vitamins
- Vitamin K 2
- Vitamin MK 7
Other Study ID Numbers
- NC27082017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Valve Disease
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaTerminatedAortic Regurgitation | Aortic Valve Insufficiency | Regurgitation, Aortic Valve | Aortic Valve | Aortic IncompetenceKorea, Republic of
-
Genesis Medtech CorporationRecruiting
-
Assistance Publique Hopitaux De MarseilleSuspendedAortic Valve Regurgitation AcquiredFrance
-
The Cleveland ClinicRecruitingAortic Stenosis | Aortic Regurgitation | Valve Heart DiseaseUnited States
-
Han Yaling, MDRecruitingCardiac Rehabilitation | Valve Disease, AorticChina
-
Na Homolce HospitalCentre of Cardiovascular and Transplantation Surgery, Czech Republic; St. Anne... and other collaboratorsRecruitingAortic Valve RegurgitationSerbia, Czechia, Belgium
-
Oslo University HospitalCompletedCoronary Artery Disease. | Aortic Valve Stenosis. | Aortic Valve Regurgitation.Norway
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingAortic Regurgitation | Transcatheter Aortic Valve ReplacementChina
-
Fondazione Policlinico Universitario Agostino Gemelli...Enrolling by invitationAortic Valve Stenosis | Heart Valve Diseases | Aortic Regurgitation | Aortic Valve Insufficiency | Aortic Stenosis, Severe | Regurgitation, Aortic | Stenoses, Aortic | Coronary; Obstruction | Valve Disease, AorticItaly
-
UMC UtrechtTerminatedPeriprosthetic Aortic Valve Regurgitation After TAVINetherlands
Clinical Trials on Vitamin K2 (Menaquinone 7) + Vitamin D3
-
Augusta UniversityYale University; University of Alabama at Birmingham; Tufts UniversityUnknownObesity | Diabetes | Insulin Resistance | Dyslipidemia | Insulin Sensitivity | PrediabetesUnited States
-
Augusta UniversityUnknownHyperglycemia | Cardiovascular Diseases | Obesity | Insulin Resistance | Hyperlipidemia | Nutritional and Metabolic Diseases | Obesity in DiabetesUnited States
-
Sola Aoun Bahous, M.D. Ph.D.Omicron Pharmaceuticals; Lesaffre InternationalNot yet recruitingMigraine Headache | Arterial Stiffness | Vitamin K DeficiencyLebanon
-
Odense University HospitalActive, not recruiting
-
Augusta UniversityYale University; University of Alabama at Birmingham; Tufts UniversityUnknownObesity | Insulin Resistance | Insulin Sensitivity | Prediabetes | Beta-Cell DysfunctionUnited States
-
Canisius-Wilhelmina HospitalKappa Bioscience ASCompleted
-
Augusta UniversityUnknownCardiovascular Diseases | Hemodialysis | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Vitamin K DeficiencyUnited States
-
Maastricht University Medical CenterVitaKUnknownCoronary Artery DiseaseNetherlands
-
Maastricht University Medical CenterCompleted
-
Maastricht University Medical CenterCompleted