RecruitingNCT05542056

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

Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia: a Prospective Cohort Study (The PROPHECY Study)


Sponsor

University Hospital, Basel, Switzerland

Enrollment

232 participants

Start Date

Sep 26, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

  • 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

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Interventions

OTHERData 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)


Locations(3)

Hospital Universitario de Móstoles

Móstoles, Spain

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, Switzerland

Kantonsspital Baselland

Liestal, Switzerland

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NCT05542056