- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939678
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
September 9, 2019 updated by: Ole Frobert, MD, PhD, Region Örebro County
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Orebro, Sweden, 70185
- Department of Cardiology, Örebro University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with aortic valve calcification that will be treated with an aortic valve replacement
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease
Time Frame: At the time of aortic valve replacement
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Mutations in genes coding for Na/Pi-cotransporters
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At the time of aortic valve replacement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 11, 2013
Study Record Updates
Last Update Posted (Actual)
September 11, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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