A PROSPECTIVE, RANDOMIZED, OPEN LABEL, BLINDED END-POINT (PROBE) TRIAL TO EVALUATE WHETHER, AT COMPARABLE BLOOD PRESSURE CONTROL, ACE INHIBITOR THERAPY MORE EFFECTIVELY THAN NON RAS INHIBITOR THERAPY REDUCES CARDIOVASCULAR MORBIDITY AND MORTALITY IN CHRONIC DIALYSIS PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY AND/OR ARTERIAL HYPERTENSION (ARCADIA Study)

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 269 人开始时间: 2008年10月17日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•- Men and women >18 years of age who are on chronic renal replacement treatment since at least 6 months with two or three haemodialysis sessions per week - Hypertension (pre-dialysis systolic and/or diastolic BP >140/90 mmHg or post-dialysis systolic and/or diastolic BP >130/80 mmHg or ongoing antihypertensive therapy) and/or - LVH defined by a cardiac mass index >130 g/m2 for men and 100 g/m2 for women (17) within three months of enrolment. - Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 136

•- Specific indication (such as heart failure) or contraindication (such as hypersensitivity) to ACE inhibitor therapy. - Any concomitant medication with ACE inhibitors and angiotensin II receptor antagonists - Hyperkalemia (serum potassium >6 mEq/L) despite optimal control of metabolic acidosis and blood glucose (in diabetics) in patient with less then three dialysis sessions per week. - Symptomatic chronic or intradialytic hypotension. - Arrhythmias that in the Investigator judgement might be worsened by hyperkalemia (such as sinus bradycardia, delayed atrio-ventricular conduction, atrio-ventricular blocks). - CV events (stroke, acute myocardial infarction or other acute coronary syndromes) over the last three months. - Uncontrolled hyper- or hypo-thyroidism. - Active systemic disease, malignancies and any clinical condition associated with a life-expectancy of less than 2 years - Drug or alcohol abuse, psychiatric disorders and inability to understand the potential risks or benefits of the study - Pregnancy, lactation or child bearing potential and ineffective contraception

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI