Patients with cradiac failure and normal ejection fraction
Conditions
Interventions
Trade Name: Levitra
Product Name: Vardenafil
Pharmaceutical Form: Film-coated tablet
CAS Number: 224785-91-5
Other descriptive name: VARDENAFIL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concen
Sponsors
Charité Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed