Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01346891

Thiazide Diuretics Induced Hyponatremia

COMPLETED

Prospective Study on Primary Aldosteronism in Resistant Hypertension

NCT04213963

Resistant Hypertension Primary Aldosteronism Refractory Hypertension +3 more

RECRUITING

Phosphate in Blood Pressure Regulation

NCT02822131

Hypertension

COMPLETED NA

Clinical Significance of Heterozygosity for Mutations of the SLC12A3 Gene Coding for the Thiazide Sensitive Na-Cl Cotransporter

NCT02035046

Heterozygous Carriers of Gitelman Syndrome

COMPLETED NA

Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension

NCT00353652

Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. They act by inhibiting the apical Na+-Cl- -cotransporter in the distal convoluted tubules of the kidneys. Thiazides and thiazide-like diuretics often cause adverse effects, importantly a drop in plasma sodium levels that is called thiazide-induced hyponatremia (TIH). Data suggest a crucial role of urinary PGE2 in water reabsorption. Since urinary PGE2 concentrations were higher in patients with TIH, quantification of urinary PGE2 prior and after thiazide initiation might allow identification of patients at risk for TIH, presenting PGE2 as a potential novel predictive marker for the development of TIH.

This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment. Hospitalized and ambulatory patients in whom a thiazide or thiazide-like diuretic will be newly prescribed are screened for inclusion.

The study procedure contains the screening and inclusion, visit 1 before thiazide initiation, visit 2 4 weeks (+/-7days) after thiazide initiation and a 3-months follow-up (visit 3). An additional visit (visit 2.1) will only be added in case of a dose change of the thiazide or thiazide-like diuretic (4 weeks +/- 7 days after the dose change). The 2 hours- challenge is optional if the patient agrees to additional testing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thiazide-induced Hyponatremia (TIH)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with newly prescribed thiazide or thiazide-like diuretic

As the study population of this observational study shall be as representative as possible all patients with a new thiazide or thiazide-like diuretic regardless of the indication, co-morbidities and co-medication can be included.

Data and biosample collection

Intervention Type OTHER

Collection of spot urine, blood sampling, vital parameters, body weight, medical history, patient questionnaires, drinking protocol, drug diary at at Visit 1 (before thiazide initiation), at Optional 2 hours-challenge, at Visit 2 (4 weeks after thiazide initiation), at Visit 2.1 (4 weeks after dose change), at Visit 3 (3-months after thiazide initiation)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data and biosample collection

Collection of spot urine, blood sampling, vital parameters, body weight, medical history, patient questionnaires, drinking protocol, drug diary at at Visit 1 (before thiazide initiation), at Optional 2 hours-challenge, at Visit 2 (4 weeks after thiazide initiation), at Visit 2.1 (4 weeks after dose change), at Visit 3 (3-months after thiazide initiation)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly prescribed thiazide or thiazide-like diuretic
* ≥ 18 years of age
* Informed Consent as documented by signature

Exclusion Criteria

* Intake of thiazide or thiazide-like diuretic in the preceding month
* Hyponatremia (plasma sodium \<135 mmol/L) at baseline
* Acute infectious / inflammatory disease (CRP ≥ 20 mg/L \[1, 11\])
* Symptomatic urinary tract infection
* End of life care, no informed consent or inability to follow the procedures of the study, e.g., due to language barriers, psychological disorders, dementia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No