Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and... | NCT01346891

Studies
Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia

NCT01346891

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Thiazide Diuretics Induced Hyponatremia

Interventions

Not provided

Countries

Argentina

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

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 2, 2011

First Submission Date that Met QC Criteria

May 2, 2011

First Posted Date

May 3, 2011Estimated

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

Jul 5, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Name	Class
Sociedad Argentina de Hipertension Arterial (SAHA)	OTHER

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 detect if there are any differences in the coding region of SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and those thiazides consumers without hyponatremia that have demonstrated good tolerance to the drug.

Detailed Description

This is a Case Control study to compare the coding region of SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and those thiazides consumers without hyponatremia that have demonstrated good tolerance to the drug.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyponatremia Group (Cases)		Patients over 21 years old, with confirmed antecedent of thiazide-induced hyponatremia who required hospitalization with a serum sodium concentration lower than 125 meq/L.
Good Thiazide Tolerance (Controls)		Patients over 21 years old, who have consumed thiazide diuretics for more than 2 years, with a serum sodium concentration persistently over 135 meq/L.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 21 years, belonging to one of the following groups:
1. Patients who have had Thiazide induced hyponatremia with serum sodium lower than 125 meq/L included in the Institutional Registry of Hyponatremia (Cases)
2. Patients with good tolerance to chronic treatment with Thiazides tha never had associated hyponatremia (Controls)
Patients with normal serum sodium measurements before the start of the Thiazides

Exclusion Criteria:

Refusal to participate or to the informed consent process
Unclear cause of hyponatremia, or other hyponatremia cause concomitant to Thiazide diuretics
Patients related to other individuals already included in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 21 years old that require treatment with thiazide diuretics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diego H Giunta, MD	Hospital Italiano de Buenos Aires	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires		Capital Federal	Buenos Aires F.D.	C1181ACH	Argentina