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Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease

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ClinicalTrials.gov Identifier: NCT01939678
Recruitment Status : Terminated (Enrollment lower than expected)
First Posted : September 11, 2013
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County

Brief Summary:
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Furthermore, aortic valve tissue received from the operations, will be examined for the presence of Na/Pi-cotransporters, and for molecular characterization of the transporters.

Condition or disease
Aortic Valve Stenosis

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
Study Start Date : September 2013
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019





Primary Outcome Measures :
  1. Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease [ Time Frame: At the time of aortic valve replacement ]
    Mutations in genes coding for Na/Pi-cotransporters


Biospecimen Retention:   Samples With DNA
Bloodsamples and Aortic valve samples


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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with aortic valve calcification that will be treated with an aortic valve replacement
Criteria

Inclusion Criteria:

  • Patients with aortic valve calcification that will be treated with an aortic valve replacement.
  • Age ≤ 65 years.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Inability to provide informed consent
  • Earlier radiation therapy of the thorax
  • Severe renal disease (patients in treatment with dialysis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939678


Locations
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Sweden
Department of Cardiology, Orebro University Hospital
Orebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County

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Responsible Party: Ole Frobert, MD, PhD, MD, PhD, Region Örebro County
ClinicalTrials.gov Identifier: NCT01939678     History of Changes
Other Study ID Numbers: 2012-12
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction