Cardiac failure with normal ejection fraction: possible role of phosphodiesterase type 5 inhibitors - HINEF: PDE5

Charité Universitaetsmedizin Berlin0 个研究点开始时间: 2007年12月4日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•- accomplished patient information, and written informed consent of the patient
•- age between 18 and 75
•- at least 1 admission to the hospital with diagnosis cardiac insufficiency NYHA class II-IV in the past
•- negative pregnancy test
•- women of childbearing age only with highly effective contraception (defined as
•PEARL-Index < 1 %)
•- no participation in another driven study according to german drugs act (30 days before and during the trial)
•- sufficient renal function (creatinin under 1,7 mg/dl)
•- sufficient hepatic function (serum GOT, serum GPT under 60 U/l)
•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

•- pregnancy and lactation
•- women of childbearing age without highly effective contraception
•- coronary heart disease with significant stenosis after implantation of a coronary stent
•- cardiac valve diseases higher than class I (aortic, mitral and tricuspidic)
•- hypersensitivity to contrast substance
•- acute apoplexy
•- arterial hypotension (below 90/50 of Hg)
•- neoplasmatic diseases with expected survival < 18 months
•- nonarteritic anterior ischemic optic neuropathy (NAION)
•- simultaneous taking of No donators, alpha blockers and/or other PDE-5 inhibitors (Viagra, Cialis)
•- hepatic insufficiency (CHILD PHUG C)
•- renal insufficiency requiring dialysis
•- cardiac infarction or apoplexis during the last 6 months
•- retinitis pigmentosa
•- simultaneous taking of itraconazole/ketoconazole
•- HIV infection and/or taking of HIV protease inhibitors
•- active hepatitis A/B
•- hypersensitivity against vardenafil
•- Persons who are detained officially or legally to an official institute (e.g. psychiatric
•institute or prison)
•- missing willingness to storaging and transferring pseudonymous disease data within this study
•- missing willingness to cooperate

发起方

Charité Universitaetsmedizin Berlin