Aortic Valve StenosisPhase 2BASIK2NCT02917525
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI
A Phase 2 study testing Vitamin K2 in people with Aortic Valve Stenosis and Bicuspid Aortic Valve, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Bicuspid Aortic Valve
- What is being tested?
- Vitamin K2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known bicuspid aortic valve
- calcified mild to moderate aortic valve stenosis on prior echocardiography
- informed consent provided
Who cannot join
- absence of calcified aortic valve stenosis on echocardiography
- presence of severe aortic valve stenosis
- history of aortic valve repair or replacement
- accepted atrial fibrillation
- use of oral anticoagulants
- claustrophobia
Show all 11Show fewer
- presence of a pacemaker, ICD or ferromagnetic materials in the body
- life expectancy <2 years
- Pregnancy (current or wish for near future)
- soy allergy
- use of vitamin K-containing supplements
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht, 6202 AZ
Bas Kietselaer, M.D., PhD, +31 (0)43 3875093, b.kietselaer@mumc.nl
Bas Kietselaer, M.D. PhD, +31 (0)43 3875093, b.kietselaer@mumc.nl
About this study
Official title: Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study
Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD.
The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification.
Read more
In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used.
We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.
- Conditions
- Aortic Valve Stenosis, Bicuspid Aortic Valve
- Being tested
- Vitamin K2, Placebo
- Keywords
- Calcium metabolism, Matrix Gla Protein, Vitamin K2
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2 | Experimental | 22 patients will receive 360ug Vitamin K2 daily during 18 months. Receives: Dietary Supplement: Vitamin K2 |
| Placebo | Placebo comparator | 22 patients will receive placebo during 18 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic valve calcium metabolism
Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan
Measured: Measured at baseline and 6 months
Secondary outcomes (2)
Change in aortic valve calcium score
Change in aortic valve calcium score, measured on CT.
Measured: Measured at baseline, 6 and 18 months
Progression of aortic valve stenosis
Change of severity of aortic valve stenosis on echocardiography
Measured: Measured at baseline, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bas Kietselaer, M.D. PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917525
- Sponsor's protocol ID
- METC152045
- Acronym
- BASIK2
- Status last verified
- Mar 2018
- First submitted
- 26 Sep 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study
- ClinicalTrials.gov ID
- NCT02917525
- Acronym / sponsor ID
- BASIK2 / METC152045
- Conditions
- Aortic Valve Stenosis, Bicuspid Aortic Valve
- Keywords
- Calcium metabolism, Matrix Gla Protein, Vitamin K2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- 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.
Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD.
The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification.
In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used.
We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.
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 |
|---|---|---|
| Vitamin K2 | Experimental | Dietary Supplement: Vitamin K222 patients will receive 360ug Vitamin K2 daily during 18 months. |
| Placebo | Placebo comparator | Other: Placebo22 patients will receive placebo during 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- known bicuspid aortic valve
- calcified mild to moderate aortic valve stenosis on prior echocardiography
- informed consent provided
Key exclusion criteria (11 listed)
- absence of calcified aortic valve stenosis on echocardiography
- presence of severe aortic valve stenosis
- history of aortic valve repair or replacement
- accepted atrial fibrillation
- use of oral anticoagulants
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 | Dietary supplement | Vitamin K2 |
| Placebo | Other | Placebo |
Primary outcome
Change in aortic valve calcium metabolism
Time frame: Measured at baseline and 6 months
Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan
2 secondary outcomes
Change in aortic valve calcium score
Time frame: Measured at baseline, 6 and 18 months
Progression of aortic valve stenosis
Time frame: Measured at baseline, 6, 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
Bas Kietselaer, M.D. PhD principal investigator
Maastricht UMC
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 in people with Aortic Valve Stenosis and Bicuspid Aortic Valve, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 11 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 22 Mar 2018. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 Bas Kietselaer, M.D., PhD (+31 (0)43 687 5096, b.kietselaer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aortic valve calcium metabolism (time frame: Measured at baseline and 6 months). 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 22 Mar 2018.