Thiazide Diuretics Induced HyponatremiaNCT01346891
Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
An observational study of Thiazide Diuretics Induced Hyponatremia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Thiazide Diuretics Induced Hyponatremia
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 21 years old that require treatment with thiazide diuretics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires F.D., C1181ACH
About this study
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.
Read the 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.
- Conditions
- Thiazide Diuretics Induced Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thiazide Diuretics Induced HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Argentina de Hipertension Arterial (SAHA)
- Investigators
- Diego H Giunta, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346891
- Sponsor's protocol ID
- 1579
- Status last verified
- Jul 2010
- First submitted
- 2 May 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
- ClinicalTrials.gov ID
- NCT01346891
- Acronym / sponsor ID
- 1579
- Conditions
- Thiazide Diuretics Induced Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Sociedad Argentina de Hipertension Arterial (SAHA)
- Study start
- Jul 2010
- First posted
- 3 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 21 years old that require treatment with thiazide diuretics
Key inclusion criteria (4 listed)
- Patients older than 21 years, belonging to one of the following groups:
- Patients with normal serum sodium measurements before the start of the Thiazides
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
Related trials for Thiazide Diuretics Induced Hyponatremia
RecruitingObservational study
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
Thiazide-induced Hyponatremia (TIH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego H Giunta, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thiazide Diuretics Induced Hyponatremia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.