AMIND - AMIloride for the treatment of Nephrogenic Diabetes insipidus for patients with bipolar disorder treated with lithium: a randomized controlled trial - APHP200042

Assistance Publique Hopitaux De Paris0 个研究点目标入组 148 人开始时间: 2024年7月26日最近更新: 2024年8月21日

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•Adults between 18 and 70 years (age = 18 years and <70 years), -Patient with bipolar disorder, -Patient treated with lithium for at least 5 years, -Patient with a urine concentration defect defined by a maximal urine osmolality < 600 mOsm/kg, -Woman of childbearing age agreeing to use an efficient contraceptive method for 12 months

•-Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation, -Acute phase of mood disorder, -Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism, -Use of potassium supplements, -Use of heparins, -Use of trimethoprim, -Cirrhosis, -Oedemas, -Previous use of amiloride use in the 6 months prior to randomisation), -Pregnant or breastfeeding women, -Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study, -Kalemia > 5 mmol/l, -Patient refusal to participate, -Non-affiliation to a social security regimen or CMU, -Patient under State Medical Aid, -Subject deprived of freedom, subject under a legal protective measure, -Hypersensitivity or known allergy to amiloride, -Hypersensitivity to lactose, -Known adrenal insufficiency, -Concomitant use of other potassium-sparing treatment (e.g. spironolactone, angiotensin converting enzyme inhibitors (ACE), angiotensin II receptor (AT2R) antagonists, calcineurin inhibitors tacrolimus and ciclosporin), -Acute ongoing infection (less than 3 days before inclusion), -Severe heart failure (NYHA > II), -Rhythm, conduction or repolarisation disorder present on an ECG done within 12 months prior to inclusion

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