Aortic Valve DiseasePhase 2DECAV-K2NCT03305536
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
A Phase 2 study testing Vitamin K2 (Menaquinone 7) + Vitamin D3 in people with Aortic Valve Disease, run by Hopital St. Georges, Ajaltoun at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Vitamin K2 (Menaquinone 7) + Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLebanon
- Study dates
- 2 Jan 2018to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AVCS > 300 without aortic valve stenosis requiring operation
- Focus on patients with:
- Bicuspid aortic valve
- Dialysis or CKD
- Statin treatment
Who cannot join
- Use of Vitamin K antagonist
- Malabsorption Problem
- LVEF < 40%
- A life expectancy < 3 years
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Hopital Saint-George Ajaltoun
Beirut
Rodolphe Frangi, MD
About this study
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.
Read the 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
- Conditions
- Aortic Valve Disease
- Being tested
- Vitamin K2 (Menaquinone 7) + Vitamin D3
- Keywords
- AVD
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 (Menaquinone 7) + Vitamin D3Dietary supplement
Also called K2/D3
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Active comparator | 1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve Receives: Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3 |
| 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 Receives: Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Measured: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Measured: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Measured: 3 years
Secondary outcomes (4)
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
- Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l)
- Reduction of the Aortic Valve Calcification Score(AVCS)
- Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
- Improvement of the quality of life of the patients( physical activity, mobility)
Measured: 3 years
Reduction of the Aortic Valve calcification measured by CT Scan
Reduction of the Aortic Valve Calcification Score (AVCS)
Measured: 3 years
Improvement of dyspnea (at rest and effort)
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start2 Jan 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital St. Georges, Ajaltoun
- Sponsor type
- University, hospital or other
- Collaborators
- Omicron Pharmaceuticals, Nattopharma ASA
- Responsible party
- Principal investigator, Rodolph Frangi, Hopital St. Georges, Ajaltoun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305536
- Sponsor's protocol ID
- NC27082017
- Acronym
- DECAV-K2
- Status last verified
- Aug 2019
- First submitted
- 30 Aug 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
- ClinicalTrials.gov ID
- NCT03305536
- Acronym / sponsor ID
- DECAV-K2 / NC27082017
- Conditions
- Aortic Valve Disease
- Keywords
- AVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hopital St. Georges, AjaltounUniversity, hospital or other
- Collaborators
- Omicron Pharmaceuticals, Nattopharma ASA
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
- 5000 IU/d Vitamin D3 as a control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D31000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve |
| interventional | Active comparator | Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D35000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AVCS > 300 without aortic valve stenosis requiring operation
- Focus on patients with:
Key exclusion criteria (4 listed)
- Use of Vitamin K antagonist
- Malabsorption Problem
- LVEF < 40%
- A life expectancy < 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2 (Menaquinone 7) + Vitamin D3Also: K2/D3Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease | Dietary supplement | Interventional, interventional |
Primary outcome
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Time frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Time frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Time frame: 3 years
4 secondary outcomes
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
Time frame: 3 years
Reduction of the Aortic Valve calcification measured by CT Scan
Time frame: 3 years
Improvement of dyspnea (at rest and effort)
Time frame: 3 years
Improvement of the quality of life of the patients
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin K2 (Menaquinone 7) + Vitamin D3 in people with Aortic Valve Disease, run by Hopital St. Georges, Ajaltoun at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodoplh Frangi, MD (00961 9 234 202 ext. 1100, drfrangi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.