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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346891
First Posted: May 3, 2011
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sociedad Argentina de Hipertension Arterial (SAHA)
Information provided by:
Hospital Italiano de Buenos Aires
  Purpose
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.

Condition
Thiazide Diuretics Induced Hyponatremia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Estimated Enrollment: 40
Study Start Date: July 2010
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over 21 years old that require treatment with thiazide diuretics
Criteria

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
  Contacts and Locations
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): NCT01346891


Locations
Argentina
Hospital Italiano de Buenos Aires
Capital Federal, Argentina, C1181ACH
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Sociedad Argentina de Hipertension Arterial (SAHA)
Investigators
Principal Investigator: Diego H Giunta, MD Hospital Italiano de Buenos Aires
  More Information

Responsible Party: Diego Giunta, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01346891     History of Changes
Other Study ID Numbers: 1579
First Submitted: May 2, 2011
First Posted: May 3, 2011
Last Update Posted: July 6, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs