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

Conditions: Patients with cradiac failure and normal ejection fraction

Registration Number: EUCTR2007-004150-85-DE

Lead Sponsor: Charité Universitaetsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of cardiac insufficiency symptoms in patients treated additionally with vardenafil (evaluated by 6-minute-walk-test, NYHA class, ergospirometry and the Minnesota Living with Heart Failure Questionnaire) ;Secondary Objective: Improvement of the diastolic function (evaluated by invasive cardiac catheter and non-invasive echocardiography) as cardiac insufficiency parameter NT-pro-BNP, IL-6 and CRP in patients treated additionally with vardenafil;Primary end point(s): Improvement of cardiac insufficiency symptoms in patients treated additionally with vardenafil (evaluated by 6-minute-walk-test, NYHA class, ergospirometry and the Minnesota Living with Heart Failure Questionnaire)

Secondary Outcome Measures