Woman and men suffering from heart failure NYHA II-IV and secondary pulmonary hypertension Objectives PVR improvement after a 12 week oral Pentalong® therapy in addition to standard long-term HF medication as well as improvement on exercise capacity (6MWD), quality of life (QOL-Questionaire), PAPsyst, LVEF, FS, TAPSE (echocardiography) at rest, PCWP, PAPs, PAPd, PAPm, RAP, RVSD, RVEDP (right heart catheter) at rest, biomarkers NTproBNP
Conditions
Interventions
Trade Name: PENTALONG 80mg
Product Name: PENTALONG 80
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Actavis GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written Informed Consent before randomization - Men or women >18 and 30mmHg, PCW >15 mmHg, LVEF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Cardiogenic shock - Acute circulatory failure - Acute decompensated heart failure (new occurrence of congestive signs) - Myocarditis - Implantation of CRT less than 12 months - Listed for HTx on high urgency status - Uncontrolled hypotension (systolic blood pressure 200mmHg) - Insufficient HF treatment not following ESC guidelines - Not on stable treatment for at least three months - Initiation of any of the following medications within the last 8 weeks: Aspirin, statins, calcium channel blockers, ACE-inhibitors or AT-1 receptor blockers, hormone replacement therapy. - Use of phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates, i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate, or molsidomin within the last two weeks. - Treatment with hydralazin - Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy - Renal dysfunction (creatinine > 2.5 mg/dl) - Known hepatic disease (including hepatitis) or elevation of serum transaminases or ?GT > 5x ULN (upper limit of normal range) - Confirmed diagnosis of HIV infection - WBC >16.000 or platelet count >500.000/µl or <75.000/µl - Clinically overt hyperthyreodism - Suspected hyperthyreodism - Suspected Thyroid Carcinoma - Febrile illnesses - Known drug (alcohol) abuse - Pregnancy and lactation - Known intolerance to organic nitrates - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product - X-ray contrast media allergy - Other significant laboratory abnormalities that the investigator feels may compromise the patient’s safety by participation in the study - Participation in other clinical trials and observation period of competing trials, respectively - Intoxication - Acute coronary syndrome - Missing informed consent No patient will be enrolled in this trial more than once.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Superiority in PVR improvement after a 12 week oral Pentalong® therapy in addition to standard long-term heart failure (HF) medication in patients suffering from HF;Secondary Objective: Effects of Pentalong® therapy on exercise capacity (6MWD), quality of life (QOL Questionaire), PAPsyst, LVEF, FS, TAPSE (echocardiography) at rest, PCWP, PAPs, PAPd, PAPm, RAP, RVSD, RVEDP (right heart catheter) at rest, biomarkers NTproBNP (optional: Troponin-I, MR-proADM, CT-proET-1), optional Peak VO2 and VO2 at AT (CPET) Optional Analyses of the effects on the total genomic expression profiles.;Primary end point(s): PVR improvement after a 12 week oral Pentalong® | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. H. Theodor Schneider
ScientificMedicalServices
Outcome results
None listed