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

This study has been completed.
Sponsor:
Collaborator:
Sociedad Argentina de Hipertension Arterial (SAHA)
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01346891
First received: May 2, 2011
Last updated: July 5, 2011
Last verified: July 2010
  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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Diego Giunta, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01346891     History of Changes
Other Study ID Numbers: 1579
Study First Received: May 2, 2011
Last Updated: July 5, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014