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 | Status | |
|---|---|---|
Locations Investigative Site Pittsburgh, United States, 15212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santander, Spain, 39008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Singapore, 169609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 308433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 768828 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80331 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1220 | Status Completed | Contact Us: E-mail: [email protected]hcare.com Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buffalo, United States, 14215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fountain Valley, United States, 92708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milwaukee, United States, 53215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sherbrooke, Canada, J1G 2E8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5B 1W8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sneek, Netherlands, 8601 ZR | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEEUWARDEN, Netherlands, 8934 AD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szekesfehervar, Hungary, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lugano, Switzerland, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 10034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 6, Czech Republic, 169 02 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MECHELEN, Belgium, 2800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MOL, Belgium, 2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GILLY, Belgium, 6060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HEERENVEEN, Netherlands, 8441 PW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rehovot, Israel, 7610001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hadera, Israel, 3810101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 92-213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 61-848 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 93-513 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olsztyn, Poland, 10-010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ancona, Italy, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUGGE, Belgium, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsingborg, Sweden, 251 87 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aalborg, Denmark, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kistarcsa, Hungary, H-2143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 236-0051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-5188 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-8526 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-1096 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Himeji, Japan, 670-0981 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Komatsushima, Japan, 773-8502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tokushima, Japan, 770-8539 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiroshima, Japan, 734-8530 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 862-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 850-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlstad, Sweden, 652 30 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232-8802 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taoyuan, Taiwan, China, 33305 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung, Taiwan, China, 813 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newark, United States, 07103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa City, United States, 52242 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PESSAC, France, 33604 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen, France, 76031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31403 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 701 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611-2908 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minato-ku, Japan, 106-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokosuka, Japan, 238-8567 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 599-8247 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iizuka, Japan, 820-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zrifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9103102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 4, Czech Republic, 140 21 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Macon, United States, 31201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55422 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kromeriz, Czech Republic, 767 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Orleans, United States, 70112-1396 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Germantown, United States, 38138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stevenage, United Kingdom, SG1 4AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S44 5DX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hobart, Australia, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DARLINGHURST, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ft. Lauderdale, United States, 33308 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 39216-4505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HUY, Belgium, 4500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint-Jean-sur-Richelieu, Canada, J3A 1C3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H2W 1T8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1309 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tiberias, Israel, 1528001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takamatsu, Japan, 760-0018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H1T 1C8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site El Palmar, Spain, 30120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naha, Japan, 902-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naples, United States, 34102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Arezzo, Italy, 52044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Krozingen, Germany, 79189 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burgas, Bulgaria, 8018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Redcliffe, Australia, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4064 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRON Cedex, France, 69677 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 70-965 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holbaek, Denmark, 4300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Homburg, Germany, 61348 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randers, Denmark, 8930 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chaidari, Greece, 12462 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nea Ionia / Athens, Greece, 142 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Taipei City, Taiwan, China, 220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1449-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1500-650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Almada, Portugal, 2801-951 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uji, Japan, 611-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Status Completed | 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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