Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD

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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Surgery in Patients With Native Aortic Valve Stenosis Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis Study to Improve Outcomes in Aortic Stenosis Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Severe Aortic Stenosis in Patients Referred for Valve Surgery Frailty and Mortality in Older Old With Severe Aortic Stenosis Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis – a Prognostic Marker and a Target for Intervention? PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD

Official Title

Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD

Brief Summary

      Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb),
      cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate
      concretions in the lungs as seen in Pulmonary Alveolar Microlithiasis (PAM). Extra pulmonary
      calcifications, including heart valve calcification, have previously been reported in
      patients with PAM.

      Calcific Aortic Valve Disease (CAVD) is a common disease in the elderly and is characterised
      by thickening and calcification of the aortic valve leaflets in the absence of rheumatic
      heart disease. CAVD is present in more than 25% of patients older than age 65 years and is
      associated with an increased risk of cardiovascular events. Currently, there is no effective
      therapy for the disease other than surgical aortic valve replacement. Both calcium and
      phosphate are the major components of calcific deposits in PAM and CAVD. Based on these
      preliminary findings, the investigators hypothesize that mutations in sodium phosphate
      co-transporters may play a role in both pulmonary and extra pulmonary calcifications.

      Two studies will be performed: 1. A retrospective cross-sectional study including patients
      with an age ≤ 65 years with CAVD from Denmark and Örebro, will be carried out. Genetic
      association analysis will be performed to investigate the incidence of common variants in
      five genes representing sodium phosphate co-transporters (SLC34A1, SLC34A2, SLC34A3, SLC20A1,
      SLC20A2) compared to healthy controls. Associated genes will subsequently be sequenced to
      identify possible causal mutations. 2. In a prospective study, aortic valve tissue will be
      collected from patients with AS undergoing surgical valve replacement. Molecular
      characterisation of the transporters will be conducted by determining the level of specific
      mRNA and protein by RT-PCR/qPCR, and Western Blotting, respectively. The localisation and
      visualisation will be investigated by immunostaining and confocal laser microscopy.
      Fibroblasts and endothelial cells will be isolated and grown in cultures with subsequent
      functional studies of the phosphate uptake.

Study Type

Observational

Primary Outcome

Frequencies of single-nucleotide polymorphisms in genes encoding NaPi co-transporters

Condition

Aortic Valve Calcification

Study Arms / Comparison Groups

 Aortic valve calcification
Description:  Patients with calcific aortic valve disease, age = 65 years or below

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

600

Start Date

May 2014

Completion Date

April 2019

Primary Completion Date

April 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Aortic valve calcification

          -  Informed consent before study participation

          -  Age: ≥ 18 years ≤ 65 years

        Exclusion Criteria:

          -  Lacking ability to give informed consent

          -  Radiotherapy towards the thorax

          -  Severe kidney disease (in dialysis)

Gender

All

Ages

N/A - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ulf Simonsen, Professor, +45 40513516, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT02516800

Organization ID

AV-SLC-2014-01

Responsible Party

Sponsor

Study Sponsor

University of Aarhus

Study Sponsor

Ulf Simonsen, Professor, Study Chair, Department of Biomedicine, Aarhus University

Verification Date

May 2017