Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI

Aortic Valve Stenosis Clinical Trial

— BASIK2  

Official title:

Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917525
• Other study ID #: METC152045
• Status: Recruiting
• Phase: Phase 2
• First received: September 26, 2016
• Last updated: March 21, 2018
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Maastricht University Medical Center
• Contact: Bas Kietselaer, M.D., PhD
• Phone: +31 (0)43 687 5096
• Email: b.kietselaer[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• known bicuspid aortic valve

• calcified mild to moderate aortic valve stenosis on prior echocardiography

• informed consent provided

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid Aortic Valve
• Constriction, Pathologic
• Heart Valve Diseases

Intervention

Dietary Supplement:
• Vitamin K2

Other:
• Placebo

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at baseline and 6 months
Secondary	Change in aortic valve calcium score	Change in aortic valve calcium score, measured on CT.	Measured at baseline, 6 and 18 months
Secondary	Progression of aortic valve stenosis	Change of severity of aortic valve stenosis on echocardiography	Measured at baseline, 6, 12 and 18 months