THINK - intensification of blood pressure lowering Therapeutics based on diuretics versus usual management for uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease: an open label, cluster randomized controlled, phase 3 trial - DR210320

Centre Hospitalier Regional Universitaire De Tours0 个研究点目标入组 720 人开始时间: 2022年10月19日最近更新: 2024年7月22日

适应症

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•Male or female =18 years and <80 years of age, Participant covered by or entitled to social security, Written informed consent obtained from the participant, Advanced or moderate chronic kidney disease (eGFR 15.0 to 44.9 ml/mn/1.73m² using CKD-Epi formula), Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients, stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs., Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (> 135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring.

•Patient following any measures of legal presentation, Symptomatic orthostatic hypotension, Hyponatremia (<130 mmol/L), Dyskalemia (<3,5 mmol/L or >5,5 mmol/L), Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke, Current medical history of cancer requiring chemotherapy, Solid organ transplantation, woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system), Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics), Mineralocorticoid receptor antagonists, Autosomal dominant polycystic kidney disease treated with Tolvaptan, Contraindication to diuretics involved in the algorithm, Severe heart failure (NYHA III_IV), Cirrhosis Child B-C, Pregnant or breastfeeding woman, Clinical signs of hypovolemia

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