The Aortic Valve DECalcification (AVADEC) Trial

Aortic Valve Stenosis Clinical Trial

— AVADEC  

Official title:

The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243890
• Other study ID #: AVADEC
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed, thus presently the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The investigators hypothesize that MK-7 supplementation will slow down the calcification process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

Participants in the Danish Cardiovascular Screening Trial (Trials. 2015 Dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible.

Exclusion Criteria:

• Known aortic valve disease (peak velocity =3.0 m/s)

• History of venous thrombosis or other coagulation disorders or use of vitamin K antagonists

• Disorders of calcium and phosphate metabolism

• A life-expectancy < 5 years

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Multidetector Computed Tomography
• Randomised Clinical Trial
• Vitamin K 2

Intervention

Dietary Supplement:
• Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).
• Placebo
Half of the patients are randomized to placebo treatment (no active treatment).

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Odense University Hospital	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Axel Diederichsen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Lindholt JS, Frandsen NE, Fredgart MH, Øvrehus KA, Dahl JS, Møller JE, Folkestad L, Urbonaviciene G, Becker SW, Lambrechtsen J, Auscher S, Hosbond S, Alan DH, Rasmussen LM, Gerke O, Mickley H, Diederichsen A. Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial. BMJ Open. 2018 Aug 23;8(8):e022019. doi: 10.1136/bmjopen-2018-022019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic valve calcification	The primary endpoint is the change in aortic valve calcification. The natural history of the aortic valve calcification is not adequately understood, and accordingly the changes are analyzed in two prespecified patient subgroups (AVC score 300-599 and =600, respectively).	From baseline to two years of follow-up
Secondary	Arterial calcification	Change in compiled arterial calcification by non-contrast CT	From baseline to two years of follow-up
Secondary	Aortic size	Change in aortic diameter	From baseline to two years of follow-up
Secondary	Coronary plaque composition	Change in total plaque burden in the coronaries and carotid arteries by contrast CT	From baseline to two years of follow-up
Secondary	Aortic valve area	Change in aortic valve area by transthoracic echocardiography	From baseline to two years of follow-up
Secondary	Bone mineral density	Change in bone mineral density as quantitative CT of the columna lumbalis and hip region	From baseline to two years of follow-up
Secondary	Biomarkers of calcification	Change in matrix-Gla proteins and osteocalcin with different phosphorylation (p and dp) and carboxylation forms (c and uc).	From baseline to two years of follow-up
Secondary	Quality of life	Change in quality of life	From baseline to two years of follow-up

External Links

•   Protocol