Ausgelaufene Studien

Patients/subjects eligible for inclusion in this study must fulfill all of the following criteria:

• Patients must give written informed consent before any assessment is performed and must be willing and capable to comply with all study procedures
• Male Outpatients ≥ 18 and ≤ 75 years of age
• Patients with a diagnosis of CHF NYHA class II and reduced ejection fraction (< 40%) (assessed by any local measurement using echocardiography, CT scanning, MRI or ventricular angiography ≤ 6 months prior to Visit 1)
• Plasma NT-proBNP level of ≥ 300 pg/mL at Visit 1
• Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior to Visit 1
• Patients must have a mild to moderate erectile dysfunction determined using the IIEF-5 questionnaire (> 7 and ≤ 21 IIEF units) at Visit 1 and Visit 2
• No usage of any available drug for erectile dysfunction (e.g. sildenafil, tadalafil) for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2
• Patients must be on an ACEI or an ARB at a stable dose for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2
• Patients must be treated with a stable dose of bisoprolol/metoprolol, unless the use of β-blockers is contraindicated or not tolerated (reason should be documented) for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2 (β-blockers other than bisoprolol/metoprolol are not allowed per protocol)
• Patients must be literate in German

Patients/subjects fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients/subjects.

• Use of other investigational drugs during the study and within 30 days or 5 half-lives, whichever is longer before enrolment and at enrolment
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
• Previous history of intolerance to recommended target doses of ACEIs or ARBs
• Known history of angioedema
• Requirement of treatment with a dual RAAS blockade, e.g. a treatment with both, ACEIs and ARBs or concomitant treatment with aliskiren
• Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
• Symptomatic hypotension and/or a systolic blood pressure (SBP) ≤100 mm Hg at Visit 1 (Screening) or Visit 2 (Randomization)
• Estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m² at Visit 1 (Screening) or Visit 2 (Randomization) as calculated by MDRD formula
• erum potassium level > 5.2mmol/L at Visit 1 (Screening) or Visit 2 (Randomization)
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1
• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1
• Implantation of a pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker / defibrillator (CRT-P/D), or upgrade of an existing device or revision of device leads within 3 months prior Visit 1 or intent to implant such a device during the study
• Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD
• History of severe pulmonary disease including COPD (Patients with significant chronic obstructive pulmonary disease contributing to dyspnea or patients whose COPD medication has been altered within 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2)
• Diagnosis of chemotherapy induced cardiomyopathy within the 12 months prior to Visit 1
• Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to Visit 1
• Known symptomatic bradycardia or second or third degree heart block without a pacemaker
• Known presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation due to left ventricular dilatation
• Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis
• Known history of familial long QT syndrome or known family history of Torsades de Pointes
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following: • AST or ALT values exceeding 2 x upper limit of normal (ULN) • History of active inflammatory bowel disease during the 12 months before Visit 1 • Current duodenal or gastric ulcers during the 3 months prior to Visit 1 • Gastric bypass • Evidence of severe hepatic impairment, biliary cirrhosis or cholestasis, classified as Child-Pugh C • History of hepatic encephalopathy, history of esophageal varices, history of portocaval shunt • Active treatment with bile sequestering agents such as cholestyramine or colestipol resins
• Presence of any other disease with a life expectancy of < 1 years
• Presence of known bilateral renal artery stenosis
• Penile anatomical defects and Peyronie’s disease
• Foreseeable usage of any available drug for erectile dysfunction (e.g. sildenafil, tadalafil) during the study
• Co-Medication with an influence on erectile function such as digoxin, anticholinergic anti-depressants, alpha blockers finasteride and calcium channel blockers
• Recent (4 weeks prior to Visit 1) or planned (within the 14 weeks after Visit 1) change in statin or spironolactone therapy
• Diabetes mellitus Type I or insulin-dependent Type II
• Prostate-specific antigen (PSA) levels higher than 4 ng/mL at Visit 1 or known prostate cancer
• Spinal cord injury, ileostomy, prior surgery or radio therapy for rectal or prostate cancer and radical prostatectomy
• Presence of peripheral artery occlusive disease and/or stenosis of the common and internal iliac artery
• Patients with ongoing alcohol and/or drug abuse and/or severe depression (defined as patients with altered medication or hospitalization within 4 weeks prior to Visit 1 and Visit 2)
• Presence and suspicion of any neurodegenerative disease or polyneuropathy
• Hormonal abnormalities such as hypogonadism, hyperprolactinemia, hyper- and hypocortisolism and medically untreated hyper- and hypothyroidism
• Obesity based on a body mass index ≥35 kg/m2, frail patients or patients with cardiac cachexia or a body mass index <18.5 kg/m2
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.