Clincosm LogoSign in Get a demo

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

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Completed
CT.gov ID
NCT01346891
Collaborator
Sociedad Argentina de Hipertension Arterial (SAHA) (Other)
40
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
    Study Start Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Patients older than 21 years, belonging to one of the following groups:

      2. Patients who have had Thiazide induced hyponatremia with serum sodium lower than 125 meq/L included in the Institutional Registry of Hyponatremia (Cases)

      3. Patients with good tolerance to chronic treatment with Thiazides tha never had associated hyponatremia (Controls)

      4. 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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01346891
      Other Study ID Numbers:
      • 1579
      First Posted:
      May 3, 2011
      Last Update Posted:
      Jul 6, 2011
      Last Verified:
      Jul 1, 2010
      Additional relevant MeSH terms:
      Hyponatremia

      Study Results

      No Results Posted as of Jul 6, 2011