Investigating urinary prostaglandin levels to predict thiazide-induced low sodium levels
Official title: Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia: a Prospective Cohort Study (The PROPHECY Study)
Run by University Hospital, Basel, Switzerland · NCT05542056 · Data updated 2026-11-12
This study is trying to see if measuring a specific substance in urine can help predict if people starting thiazide diuretics will develop low sodium levels.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 232 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Móstoles and 2 other locations) |
| Status | Recruiting |
| Started | September 26, 2022 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT05542056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are newly prescribed thiazide or thiazide-like diuretics.
✕Probably not a fit
Patients who have taken thiazide or thiazide-like diuretics in the past month or those with existing hyponatremia will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to determine if baseline urinary prostaglandin E2 (PGE2) concentrations can predict the risk of thiazide-induced hyponatremia (TIH) in patients starting thiazide or thiazide-like diuretics. Patients will be screened and included if they are newly prescribed these medications, and their urinary PGE2 levels will be measured before treatment and again after four weeks. The study will involve follow-up visits to monitor sodium levels and assess any changes in medication dosage. The goal is to identify a potential predictive marker for TIH, which could help in managing patients at risk.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients at risk for thiazide-induced hyponatremia, allowing for more personalized treatment plans.
How similar studies have gone: While the role of urinary PGE2 in TIH is suggested, this approach is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * Chronic treatment with NSAID and / or NSAID intake 48 hours prior to urine sampling at visit 1 and 2 (intake of acetylsalicylic acid will be no exclusion criteria) * 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
Where it's running
-
Hospital Universitario de Móstoles
Móstoles, Spain Recruiting -
University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, Switzerland Recruiting -
Kantonsspital Baselland
Liestal, Switzerland Recruiting
Study contacts
- Principal investigator: Mirjam Christ-Crain, Prof. Dr. med. — University Hospital Basel, Endocrinology, Diabetes and Metabolism
- Study coordinator: Julia Beck, Dr. med.
- Email: julia.beck@usb.ch
- Phone: +41 61 328 54 37
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.