Heart failure MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: BAY 1753011 30mg
Product Code: BAY 1753011
Pharmaceutical Form: Coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: BAY 1753011
Other descriptive name: BAY175301
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed before any study-specific procedure. 2. Ability to understand and follow study-related instructions as a documented decision of the investigator. 3. Men and women aged = 18 years = 85 years. Lower age limit may be higher if legally requested in the participating country. 4. Men must agree to use condoms during sexual intercourse. 5. Women can only be enrolled if of non-child bearing potential 6. History of CHF (HF with reduced, preserved or mid-range EF) on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks prior to index hospitalization and in accordance with international guidelines. 7. Subjects admitted to the hospital with a primary diagnosis of decompensated HF including symptoms and signs of fluid overload requiring IV diuretic therapy in the ER or any time between day 1-3 of hospital admission AND 8. Subjects on an average/usual total daily dose of loop diuretic = 40mg of furosemide or equivalent, within 4 weeks prior to index hospitalization. AND 9. At least one of the following 5 parameters any day between 3-7 of index hospitalization Ai. Drop in BNP or NT-proBNP = 30% from admission values (if measured during index hospitalization) or Aii. BNP = 500 pg/ml or NT-proBNP = 1800 pg/ml at screening B. BW loss 21 mm Eiii. IVC collapse with sniff =65 years) yes F.1.3.1 Number of subjects for this age range 310
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) 35 kg/m2 2. Known hypersensitivity to the study drugs 3. Participation in another interventional clinical study or treatment with investigational medicinal product 30 days or five half-lives of the investigational drug prior to screening 4. Any other condition or therapy that would make the subject unsuitable for this study and would not allow participation for the full planned study period in the judgment of the investigator (e.g. severe Chronic Obstructive Pulmonary Disease (COPD), Severe chronic infectious disease [endocarditis, H.I.V., etc.]) 5. Malignancy or other non-cardiac condition limiting life expectancy to 110 BPM (in case of AF > 120 BPM) at the time of screening or at randomization 18. Symptomatic hypotension with systolic BP < 95 mmHg during screening or at randomization 19. Any systolic BP < 85 mmHg during screening or at randomization 20. Complex congenital heart disease 21. Sepsis or ongoing systemic inflammation 22. Hypertrophic obstructive or restrictive cardiomyopathy 23. Requirement of mechanical support or ultrafiltration/hemodialysis 24. Use of IV vasodilators or IV inotropic support within 24 hours prior to randomization or tolvaptan at any time during index hospitalization 25. Estimated GFR of < 30 ml/min/1.73 m2 determined by the MDRD equation at screening 26. Serum potassium = 5.5 mmol/L or = 3.3 mmol/L at screening 27. Serum sodium = 146 mmol/L or = 130 mmol/L at screening 28. Hepatic insufficiency classified as Child-Pugh B or C 29. Syndrome of Inappropriate Antidiuretic Hormone Secretion 30. Diabetes insipidus 31. Thyroid disease requiring current treatment and/or (sub)clinical hyperthyroidism or hypothyroidism 32. Concomitant treatment with potassium-sparing diuretic (with the exception of MRA) that cannot be stopped prior to randomization and for the duration of the treatment period 33. Concomitant treatment with strong and moderate inducers or inhibitors of CYP3A4 34. Concomitant treatment with probenecid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 30 mg of BAY 1753011, with or without furosemide, versus furosemide alone in patients with HF and objective evidence of congestion ;Secondary Objective: To assess the safety and pharmacodynamics of 30 mg of BAY 1753011, with or without furosemide, versus furosemide alone in patients with HF and objective evidence of congestion;Primary end point(s): PART A: Change in body weight and serum creatinine (Day 1 vs. Day 30) PART B: Change in body weight and BUN/creatinine ratio (Day 30 vs. Day 60) ;Timepoint(s) of evaluation of this end point: Day 30 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety by TEAE reporting (including SAE) • Pharmacodynamics by change in augmentation index ;Timepoint(s) of evaluation of this end point: Day 30 and day 60 | — |
Countries
Austria, Bulgaria, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Spain
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed