E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with cradiac failure and normal ejection fraction |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |