Trial Condition(s):
Heart Failure
Phase IIb safety and efficacy study of four dose regimens of BAY1021189 in patients with heart failure and preserved ejection fraction suffering from worsening chronic heart failure (SOCRATES-PRESERVED)
Bayer Identifier:
15829
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)
Inclusion Criteria
- Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization - Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
Exclusion Criteria
- Intravenous inotropes at any time after hospitalization
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Pittsburgh, United States, 15212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | 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 Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08023 | 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 Santander, Spain, 39008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Singapore, 169609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 308433 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 768828 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | 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 Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80331 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48149 | 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 Wien, Austria, 1220 | 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 St. Pölten, Austria, 3100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buffalo, United States, 14215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fountain Valley, United States, 92708 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sherbrooke, Canada, J1G 2E8 | 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 Quebec, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sneek, Netherlands, 8601 ZR | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEEUWARDEN, Netherlands, 8934 AD | 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, 1097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 6, Czech Republic, 169 02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MECHELEN, Belgium, 2800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MOL, Belgium, 2400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GILLY, Belgium, 6060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HEERENVEEN, Netherlands, 8441 PW | 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 Petah 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, 6423906 | 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 Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 92-213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 61-848 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 93-513 | 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 Olsztyn, Poland, 10-010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUGGE, Belgium, 8000 | 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 Helsingborg, Sweden, 251 87 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aalborg, Denmark, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kistarcsa, Hungary, H-2143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 236-0051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-5188 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-1096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Himeji, Japan, 670-0981 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Komatsushima, Japan, 773-8502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tokushima, Japan, 770-8539 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiroshima, Japan, 734-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 862-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 850-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlstad, Sweden, 652 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232-8802 | 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, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taoyuan, Taiwan, China, 33305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung, Taiwan, China, 813 | 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 Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PESSAC, France, 33604 | 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 Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611-2908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minato-ku, Japan, 106-0031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokosuka, Japan, 238-8567 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 599-8247 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iizuka, Japan, 820-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zrifin, Israel, 7030000 | 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 Praha 4, Czech Republic, 140 21 | 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 Minneapolis, United States, 55422 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kromeriz, Czech Republic, 767 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Orleans, United States, 70112-1396 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Germantown, United States, 38138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stevenage, United Kingdom, SG1 4AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S44 5DX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hobart, Australia, 7000 | 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 Ft. Lauderdale, United States, 33308 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 39216-4505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HUY, Belgium, 4500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1527 | 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 Montreal, Canada, H2W 1T8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1202 | 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, 1233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tiberias, Israel, 1528001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takamatsu, Japan, 760-0018 | 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 Linz, Austria, 4020 | 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 Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naha, Japan, 902-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naples, United States, 34102 | 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 Bergamo, Italy, 24127 | 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 Bad Krozingen, Germany, 79189 | 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 Redcliffe, Australia, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4064 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRON Cedex, France, 69677 | 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 Szczecin, Poland, 70-965 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holbaek, Denmark, 4300 | 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 Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Homburg, Germany, 61348 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randers, Denmark, 8930 | 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, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nea Ionia / Athens, Greece, 142 33 | 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 Lisboa, Portugal, 1449-005 | 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, 1649-035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uji, Japan, 611-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY1021189 over 12 weeks in patients with worsening heart failure and preserved ejection fraction (HFpEF)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP)Timeframe: Baseline and 12 weeks
- Change of left atrial volume (LAV)Timeframe: Baseline and 12 weeks
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to 4 months
Additional Information
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