ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial - ALCHEMIST

CHRU de Brest0 sites825 target enrollmentJuly 17, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 17, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CHRU de Brest

•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