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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01346891
Other study ID # 1579
Secondary ID
Status Completed
Phase N/A
First received May 2, 2011
Last updated July 5, 2011
Start date July 2010

Study information

Verified date July 2010
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Capital Federal

Sponsors (2)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires Sociedad Argentina de Hipertension Arterial (SAHA)

Country where clinical trial is conducted

Argentina,