A randomised double blind placebo controlled trial to investigate the effects of long term treatment with the aldosterone receptor antagonist eplerenone on left ventricular mass and volume with magnetic resonance imaging in asymptomatic aortic stenosis

Pfizer (Investigator initated trial conducted independently of sponsor)0 个研究点目标入组 66 人开始时间: 2006年4月6日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Aortic stenosis with peak velocity across valve by doppler of >3.0m/s, normal left ventricular function by echocardiography, asymptomatic for aortic stenosis.

•Known sensitivity to study medication or spironolactone, age < 18 years, previous aortic valve replacement or scheduled aortic valve replacement with 3 months, other significant heart valve disease of > moderate severity, acute coronary syndrome within previous 6 months, signficant co-morbidity, use of potassium sparing diuretics, serum creatinine >0.13mmol/l during screening period, serum potassium >5.0mmol/l during the screening period, likely poor compliance, gastrointestinal disease which may interefer with the absorption, pharmacokinetics or elimination of eplerenone, left ventricular outlfow obstrcution from a cause other than aortic stenosis, contrindication to magnetic resonance imaging, current enrolment in an investigational drug or device trial, pregant or lactating women or potential for conception, or any condition which in the patient's doctors opinion makes participation in the trial not in the best interest of the patient.

发起方

Pfizer (Investigator initated trial conducted independently of sponsor)