Heart failure MedDRA version: 18.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Sponsors
Bayer HealthCare 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 3. Worsening chronic heart failure requiring hospitalization (or IV diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization: Diagnostic methods: - History of chronic HF: NYHA class II-IV =30 days before hospitalization (or before IV diuretic treatment for HF without hospitalization) - Worsening HF at hospitalization (or at the time of IV diuretic treatment for HF without hospitalization) - NT-proBNP =300 or BNP =100 pg/mL in sinus rhythm, or NT-proBNP =600 or BNP =200 pg/mL in A. fib. in local routine labs, and - Symptoms and signs of congestion (clinical or radiographic signs in routine chest x-ray demonstrating pleural effusion, pulmonary congestion (redistribution, interstitial or alveolar edema), or cardiomegaly - Clinical stabilization defined by - no IV vasodilator for >24h and no IV diuretic for >12h before randomization and - SBP =110 and 58 mL in male and >52 mL in female patients, or LA area >20 cm2, or LA diameter >40 mm in male and >38 mm in female patients. 4. Ability to understand and follow study-related instructions 5. Men or confirmed postmenopausal women or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy. Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 376
Exclusion criteria
Exclusion criteria: 1. Legal lower age limitations for adults (country specific) 2. IV inotropes at any time after hospitalization 3. Cardiac comorbidity (any of the following): - Chronic atrial fibrillation: after enrollment of approximately 141 patients with chronic atrial fibrillation (30% of population), chronic atrial fibrillation will be considered an exclusion criterion - History of reduced ejection fraction (EF 40 kg/m² - Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment - Severe pulmonary disease with either requirement of continuous home oxygen or recent bronchial artery embolization for massive hemoptysis - Subjects with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients - Medical condition or history thereof that in the opinion of the investigator would impair the ability to complete the planned study procedures 5. Concomitant Treatment with a PDE5 inhibitor or sGC stimulator 6. Participation in another clinical study or treatment with another investigational product =30 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: N/A;Primary end point(s): 1. Change from baseline to week 12 in left atrial volume (LAV) 2. Change from baseline to week 12 in log-transformed NT-proBNP ;Timepoint(s) of evaluation of this end point: Week 12 of treatment.;Main Objective: To find the optimal dose of BAY 1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment by characterizing the safety, tolerability, pharmacodynamic effects, and pharmacokinetics, and detecting a significant dose-response relationship in at least one of the two primary endpoints change in NT-proBNP and change of left atrial volume at 12 weeks in patients with worsening chronic heart failure with preserved ejection fraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in heart structure/function as measured by echocardiography 2. Changes in biomarkers 3. Changes to blood pressure & heart rate 4. Changes in health-related quality of life 5. Hospitalisations and death from cardiovascular causes 6. Change in NYHA function class 7. Incidence (new or recurrence) of atrial fibrillation 8. Changes in background heart failure therapies 9. Change in Composite Congestion Score;Timepoint(s) of evaluation of this end point: 1. From baseline to 12 weeks 2. From baseline to 12 weeks 3. From baseline to 12 weeks 4. From baseline to 12 weeks 5. From baseline to 16 weeks 6. From baseline to 12 weeks 7. From baseline to 16 weeks 8. From baseline to 12 weeks 9. From baseline to 12 weeks | — |
Countries
Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed