Идёт набор NCT05542056

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

— Наблюдательное Thiazide-induced Hyponatremia (TIH)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Data and biosample collection.
Кому может быть актуально: Состояния в реестре: Thiazide-induced Hyponatremia (TIH). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания, Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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)

Первичные конечные точки

Occurrence of hyponatremia (plasma sodium <135 mmol/L) [Срок оценки: Within the first four weeks of treatment (at visit 2)]

Вторичные конечные точки (12)

Change in urinary Prostaglandin- concentration [Срок оценки: 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 [Срок оценки: Between baseline, visit 2 (and visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in systolic and diastolic blood pressure [Срок оценки: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in heart rate [Срок оценки: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in body weight [Срок оценки: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in daily fluid intake [Срок оценки: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in Bioelectrical impedance analysis (BIA) [Срок оценки: Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months]
Change in plasma sodium [Срок оценки: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
Change in urine sodium [Срок оценки: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
Change in potassium [Срок оценки: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
Change in chloride [Срок оценки: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]
Change in creatinine [Срок оценки: Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет