Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data and biosample collection.
- Who it may be relevant to
- Registry conditions: Thiazide-induced Hyponatremia (TIH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia: a Prospective Cohort Study (The PROPHECY Study)
Overview
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.
Detailed description
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.
Interventions
- Other 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)
Primary outcome measures
- Occurrence of hyponatremia (plasma sodium <135 mmol/L) [Time frame: Within the first four weeks of treatment (at visit 2)]
Secondary outcome measures (12)
- Change in urinary Prostaglandin- concentration [Time frame: Between baseline, visit 2 (and visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in the expression of proteins involved in sodium and water transport [Time frame: Between baseline, visit 2 (and visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in systolic and diastolic blood pressure [Time frame: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in heart rate [Time frame: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in body weight [Time frame: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in daily fluid intake [Time frame: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in Bioelectrical impedance analysis (BIA) [Time frame: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
- Change in plasma sodium [Time frame: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
- Change in urine sodium [Time frame: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
- Change in potassium [Time frame: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
- Change in chloride [Time frame: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
- Change in creatinine [Time frame: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 2 centers
- University Hospital Basel, Endocrinology, Diabetes and Metabolism — Basel
- Kantonsspital Baselland — Liestal
Spain · 1 center
- Hospital Universitario de Móstoles — Móstoles
Identifiers
NCT: NCT05542056 · 2022-01241; kt21ChristCrain3