Characterization and Role of Mutations in Sodium-phosphat... | NCT01939678

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

NCT01939678

Sponsor

Region Örebro County

Status

Terminated

Last Update Posted

Sep 11, 2019Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment lower than expected

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2019Actual

Completion Date

Sep 2019Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Sep 5, 2013

First Posted Date

Sep 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease	Mutations in genes coding for Na/Pi-cotransporters	At the time of aortic valve replacement

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with aortic valve calcification that will be treated with an aortic valve replacement

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Orebro University Hospital		Örebro		70185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

Not provided