Role of ALiskiren, a direct renin inhibitor, in preventing atrial Fibrillation in patients with a pacemaker; RALFEteisvärinäkuorman määritys sydämentahdistimella aliskireenihoidossa - RALF

Mika Lehto0 个研究点目标入组 70 人开始时间: 2010年6月10日最近更新: 2018年5月7日

适应症

试验速览

暂无简介。

•The study population is patients from HUCH pacemaker policlinics with an earlier im-planted pacemaker because of sinus node disease and paroxysmal AF. It is antici-pated to enrol 70 patients aged 18-80 years to this study during 9 months. The follow-ing inclusion and exclusion criteria will be used for this study.
•- age between 18 and 80 years
•- sinus node disease and paroxysmal AF
•- provided signed informed consent according to the Declaration of Helsinki for study participation
•- a previously implanted St. Jude Medical Identity / Victory / Zephyr / Accent / Anthem DDDR DDDR pacemaker with ability to record high atrial rates
•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

•- contraindication for the use of aliskiren
•- severe impairment of renal function (serum creatinine > 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis
•- significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy
•- hypersensitivity to aliskiren or to any of the excipients
•- concomitant treatment with cyclosporine
•- patients with uncontrolled hypertension requiring treatment for hypertension
•- systolic blood pressure measured in two separate occasions = 160 mmHg
•- diastolic blood pressure in two separate occasions = 100 mmHg
•- absolute indication for the use of an RAAS blocker
•- chronic, persisting AF (persisting AF at screening with = 4 cardioversions performed beforehand)
•- sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisa-tion
•- need for ventricular pacing more than 30% at the enrolment
•- pregnancy and/or lactation
•- women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)
•- other serious disease expected to cause substantial deterioration of patient’s health during the next two years
•- past or present alcohol or drug abuse
•- participation in other clinical trials during the last three months
•- suspicion of poor study compliance

发起方

Mika Lehto