Trial Condition(s):
Heart Failure
Phase IIb safety and efficacy study of different oral doses of BAY94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or chronic kidney disease alone (ARTS-HF)
Bayer Identifier:
14564
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.
Inclusion Criteria
- Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country - Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active - Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital - Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV - Subjects with type 2 diabetes mellitus and / or - Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening - Left ventricular ejection fraction (LVEF) </= 40% - Blood potassium </= 5.0 mmol/L at screening - Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion Criteria
- Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis - Acute coronary syndrome (ACS) in last 30 days prior to screening - Cardiogenic shock - Valvular heart disease requiring surgical intervention during the course of the study - Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit - Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Espoo, Finland, 02740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rovaniemi, Finland, 96101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen, France, 76031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris cedex 13, France, 75013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bron, France, 69677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS cedex 10, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vandoeuvre les Nancy, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaunas, Lithuania, LT-50161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaunas, Lithuania, LT-44320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaunas, Lithuania, LT-47144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klaipeda, Lithuania, 92288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chaidari, Greece, 12462 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Copenhagen Ø, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site København NV, Denmark, 2400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hvidovre, Denmark, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Svendborg, Denmark, 5700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Køge, Denmark, 4600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Viborg, Denmark, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza Brianza, Italy, 20900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Foggia, Italy, 71100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00163 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Arezzo, Italy, 52044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97078 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stavanger, Norway, 4011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krems an der Donau, Austria, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site El Palmar, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Falun, Sweden, 791 82 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sherbrooke, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4W7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H1T 1C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint-Jean-sur-Richelieu, Canada, J3A 1C3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4Z6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Esbjerg, Denmark, 6700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wonju, South Korea, 26426 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petoria, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tongaat, South Africa, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Merebank, South Africa, 4052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pinelands, South Africa, 7405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Isipingo Rail, South Africa, 4110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuils River, South Africa, 7580 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zefat, Israel, 1311001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petach Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rehovot, Israel, 7610001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hadera, Israel, 3810101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9103102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 7030000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Macon, United States, 31201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olot, Spain, 17800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 5, Czech Republic, 150 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1085 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagykanizsa, Hungary, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stade, Germany, 21682 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava, Czech Republic, 728 80 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jindrichuv Hradec, Czech Republic, 377 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 70-965 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newark, United States, 07103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9700 RB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9728 NT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VELDHOVEN, Netherlands, 5504 DB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1061 AE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3045 PM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DELFT, Netherlands, 2625 AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOGEVEEN, Netherlands, 7909 AA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Concord, Australia, 2139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, P-4200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1500-650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Almada, Portugal, 2801-951 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Faro, Portugal, 8000-386 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taizung, Taiwan, China, 402 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 04-628 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Katowice, Poland, 40-635 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kielce, Poland, 25-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZUTPHEN, Netherlands, 7207 AE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ruse, Bulgaria, 7002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varna, Bulgaria, 9010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pazardzhik, Bulgaria, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DARLINGHURST, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burgas, Bulgaria, 8018 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nea Ionia / Athens, Greece, 14233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Larissa, Greece, 41100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35294-2041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Slany, Czech Republic, 274 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60389 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey, 06100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey, 06500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Antalya, Turkey, 07003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fairfield, United States, 45014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H2W 1T8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Limburg, Germany, 65549 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of different oral doses of BAY94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or chronic kidney disease alone versus eplerenone
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Percentage of participants with a relative decrease in NT-proBNP of more than 30% from baseline to Day 90N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.Timeframe: Baseline and Day 90
Secondary Outcome
- Number of Participants With Death due to any CauseDeath due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Number of Participants With Cardiovascular HospitalizationHospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Ratio of BNP at specified visits to BNP at baselineB-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.Timeframe: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
- Ratio of NT-proBNP at specified visits to NT-proBNP at baselineN-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.Timeframe: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
- Change from Baseline in KCCQ questionnaire scores at specified visitsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.Timeframe: Baseline, Day 30 and Day 90
- Change from Baseline in EQ-5D-3L questionnaire scores at specified visitsEuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.Timeframe: Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Additional Information
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