Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
This study has been completed.
Sponsor:
Hospital Italiano de Buenos Aires
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
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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 |
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:
Patients older than 21 years, belonging to one of the following groups:
- Patients who have had Thiazide induced hyponatremia with serum sodium lower than 125 meq/L included in the Institutional Registry of Hyponatremia (Cases)
- 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
Contacts and Locations
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 May 19, 2013