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

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.

Study Overview

• Status: Completed
• Conditions: Thiazide Diuretics Induced Hyponatremia

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over 21 years old that require treatment with thiazide diuretics

Description

Inclusion Criteria:

1. 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)
2. Patients with normal serum sodium measurements before the start of the Thiazides

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Collaborators: Sociedad Argentina de Hipertension Arterial (SAHA)

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 1579

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No