ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial - ALCHEMIST

CHRU de Brest0 个研究点目标入组 825 人开始时间: 2015年7月17日最近更新: 2018年12月4日

研究概览

暂无简介。

•Men and women over the age of at least 45 days for IRCT, regardless of the etiology including diabetes, having at least 3 HD sessions per week AND having at least one of the comorbidities, cardiovascular anomalies or risk factor CV following:
•Left ventricular hypertrophy defined by left ventricular mass> 130 g / m2 in men and 100 g / m2 in women, (echocardiography) OR Cornell index (RaVL + SV3)> 28 mm in humans,> 20 mm in women (electrocardiogram), or left ventricular ejection fraction <40%, (echocardiography); QRS wide> 0.14 sec OR Left branch block (electrocardiogram) measured in the 12 months prior to inclusion; diabetes; history of CV disease: coronary artery disease, symptomatic lower extremity arterial disease, renal or carotid artery stenosis> 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF) arrhythmia, current oral anticoagulant therapy for AF indication, valvular prosthesis cardiac or CRP> 5 mg / l for 3 months without documented infectious or neoplastic pathology AND informed written consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of hypersensitivity to spironolactone; galactose intolerance, the Lapp lactase deficiency or malabsorption of glucose or galactose; hyperkalemia > 5.5 mmol / l during the two weeks prior to enrolment, history of unscheduled hemodialysis for hyperkalemia, or hospitalization for hyperkalemia during the last six months; patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately); kidney transplant scheduled within the year; symptomatic interdialytic hypotension; acute systemic disease; uncompensated hypothyroidism, acute hyperthyroidism; any prior or concomitant clinical condition compromising the inclusion, in the discretion of the investigator; cardiac transplant; severe uncontrolled arrhythmia; stroke within 3 months prior to enrolment; acute coronary syndrome within 1 month prior to enrolment; recent (1 month) or planned coronary revascularization with angioplasty; or CV surgery outside the vascular access of the HD recent (3 months) or planned; non menopausal women or without oral contraceptives; pregnancy or planning a pregnancy within 2 years; non compliance; protected adult; SBP > 200 mmHg and/or DBP > 110 mmHg;Any concomitant treatment that can not be stopped by another potassium-sparing diuretic, potassium supplementation, NSAIDs or Cox 2 inhibitors

发起方

CHRU de Brest