NCT05542056 Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
| NCT ID | NCT05542056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Thiazide-induced Hyponatremia (TIH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 232 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 232 participants in total. It began in 2022-09-26 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Mirjam Christ-Crain, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital Basel, Endocrinology, Diabetes and Metabolism
Frequently Asked Questions
Who can join the NCT05542056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thiazide-induced Hyponatremia (TIH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05542056 currently recruiting?
Yes, NCT05542056 is actively recruiting participants. Contact the research team at julia.beck@usb.ch for enrollment information.
Where is the NCT05542056 trial being conducted?
This trial is being conducted at Móstoles, Spain, Basel, Switzerland, Liestal, Switzerland.
Who is sponsoring the NCT05542056 clinical trial?
NCT05542056 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Mirjam Christ-Crain, Prof. Dr. med. at University Hospital Basel, Endocrinology, Diabetes and Metabolism. The trial plans to enroll 232 participants.