check_circleStudy Completed

Heart Failure

Bayer Identifier:

15829

ClinicalTrials.gov Identifier:

NCT01951638

EudraCT Number:

2013-002288-25

EU CT Number:

Not Available
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)

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)

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - Intravenous inotropes at any time after hospitalization

Trial summary

Enrollment Goal
477
Trial Dates
November 2013 - September 2015
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pittsburgh, 15212, United States
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
Warszawa, 04-628, Poland
Completed
Valencia, 46026, Spain
Completed
Majadahonda, 28222, Spain
Withdrawn
L'Hospitalet de Llobregat, 08907, Spain
Completed
Barcelona, 08023, Spain
Completed
Barcelona, 08003, Spain
Completed
Santander, 39008, Spain
Withdrawn
Barcelona, 08006, Spain
Completed
169609, Singapore
Completed
Singapore, 308433, Singapore
Completed
Singapore, 768828, Singapore
Completed
Singapore, 119228, Singapore
Completed
Homburg, 66421, Germany
Completed
Erfurt, 99089, Germany
Completed
Köln, 50937, Germany
Completed
Greifswald, 17475, Germany
Completed
Hamburg, 20246, Germany
Completed
München, 80331, Germany
Completed
Münster, 48149, Germany
Completed
Graz, 8036, Austria
Completed
Wien, 1220, Austria
Completed
Salzburg, 5020, Austria
Completed
St. Pölten, 3100, Austria
Completed
Wien, 1090, Austria
Completed
Buffalo, 14215, United States
Withdrawn
Indianapolis, 46260, United States
Withdrawn
Atlanta, 30322, United States
Withdrawn
Los Angeles, 90048, United States
Completed
Fountain Valley, 92708, United States
Withdrawn
La Jolla, 92037, United States
Completed
Milwaukee, 53215, United States
Completed
Sherbrooke, J1G 2E8, Canada
Completed
Toronto, M5B 1W8, Canada
Completed
Quebec, G1V 4G5, Canada
Withdrawn
Scarborough, M1P 2V5, Canada
Withdrawn
Brampton, L6Z 4N5, Canada
Completed
Sneek, 8601 ZR, Netherlands
Withdrawn
DEVENTER, 7416 SE, Netherlands
Completed
LEEUWARDEN, 8934 AD, Netherlands
Withdrawn
Eger, 3300, Hungary
Completed
Szekesfehervar, 8000, Hungary
Completed
Budapest, 1097, Hungary
Withdrawn
Bruderholz, 4101, Switzerland
Withdrawn
Basel, 4031, Switzerland
Completed
Genève, 1205, Switzerland
Completed
Lugano, 6900, Switzerland
Completed
Praha 10, 10034, Czechia
Completed
Praha 6, 169 02, Czechia
Completed
Praha 2, 12808, Czechia
Withdrawn
Ostrava, 708 52, Czechia
Withdrawn
Hradec kralove, 500 05, Czechia
Completed
Brescia, 25123, Italy
Withdrawn
Milano, 20138, Italy
Withdrawn
Verona, 37045, Italy
Completed
Pavia, 27100, Italy
Completed
Milano, 20017, Italy
Completed
MECHELEN, 2800, Belgium
Completed
MOL, 2400, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Completed
ROESELARE, 8800, Belgium
Completed
GILLY, 6060, Belgium
Completed
HEERENVEEN, 8441 PW, Netherlands
Withdrawn
WEERT, 6001 BE, Netherlands
Completed
Ashkelon, 7830604, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Rehovot, 7610001, Israel
Completed
Hadera, 3810101, Israel
Completed
Tel Aviv, 6423906, Israel
Completed
Afula, 1834111, Israel
Withdrawn
Ramat Gan, 5262000, Israel
Withdrawn
Budapest, 1115, Hungary
Withdrawn
Jaszbereny, 5100, Hungary
Withdrawn
Kaposvar, 7400, Hungary
Withdrawn
Budapest, 1032, Hungary
Withdrawn
Burlington, 05401-1420, United States
Withdrawn
Columbus, 43210, United States
Withdrawn
Detroit, 48201, United States
Completed
Detroit, 48202, United States
Withdrawn
Wroclaw, 50-981, Poland
Completed
Krakow, 31-202, Poland
Completed
Lodz, 92-213, Poland
Completed
Poznan, 61-848, Poland
Completed
Lodz, 93-513, Poland
Withdrawn
Legnica, 59-220, Poland
Withdrawn
Katowice, 40-635, Poland
Completed
Bialystok, 15-276, Poland
Withdrawn
Warszawa, 02-507, Poland
Completed
Olsztyn, 10-010, Poland
Withdrawn
Como, 22020, Italy
Completed
Ancona, 60126, Italy
Withdrawn
Milano, 20162, Italy
Withdrawn
HASSELT, 3500, Belgium
Completed
BRUGGE, 8000, Belgium
Withdrawn
Malmö, 205 02, Sweden
Completed
Stockholm, 118 83, Sweden
Completed
Helsingborg, 251 87, Sweden
Completed
Linköping, 581 85, Sweden
Withdrawn
Viborg, 8800, Denmark
Withdrawn
Hellerup, 2900, Denmark
Withdrawn
Vejle, 7100, Denmark
Completed
Aalborg, 9000, Denmark
Completed
Kistarcsa, H-2143, Hungary
Withdrawn
Budapest, 1085, Hungary
Withdrawn
Beijing, 100037, China
Withdrawn
Shanghai, 200032, China
Withdrawn
Sendai, 981-3133, Japan
Completed
Meguro-ku, 152-8902, Japan
Completed
Yokohama, 236-0051, Japan
Completed
Sagamihara, 252-5188, Japan
Withdrawn
Seto, 489-8642, Japan
Completed
Kanazawa, 920-8650, Japan
Completed
Fukui, 910-8526, Japan
Completed
Takatsuki, 569-1096, Japan
Completed
Himeji, 670-0981, Japan
Completed
Komatsushima, 773-8502, Japan
Completed
Tokushima, 770-8539, Japan
Completed
Hiroshima, 734-8530, Japan
Completed
Kumamoto, 862-8505, Japan
Completed
Nagasaki, 850-8555, Japan
Completed
Karlstad, 652 30, Sweden
Withdrawn
Alicante, 03010, Spain
Completed
Nashville, 37232-8802, United States
Withdrawn
Cambridge, N1R 6V6, Canada
Completed
Taipei, 100, Taiwan
Completed
Taipei, 11217, Taiwan
Completed
Taoyuan, 33305, Taiwan
Completed
Kaohsiung, 813, Taiwan
Withdrawn
Zürich, 8091, Switzerland
Completed
Newark, 07103, United States
Completed
Iowa City, 52242, United States
Withdrawn
PARIS CEDEX 15, 75908, France
Completed
PESSAC, 33604, France
Withdrawn
BREST, 29609, France
Withdrawn
Lille Cedex, 59037, France
Completed
Rouen, 76031, France
Completed
TOULOUSE, 31403, France
Withdrawn
PARIS cedex 10, 75475, France
Completed
Örebro, 701 85, Sweden
Completed
Toyama, 930-8550, Japan
Withdrawn
Omaha, 68131, United States
Completed
Chicago, 60611-2908, United States
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
Minato-ku, 106-0031, Japan
Completed
Yokosuka, 238-8567, Japan
Completed
Sakai, 599-8247, Japan
Withdrawn
Yao, 581-0011, Japan
Completed
Iizuka, 820-8505, Japan
Completed
Zrifin, 7030000, Israel
Completed
Jerusalem, 9103102, Israel
Completed
Praha 4, 140 21, Czechia
Completed
Macon, 31201, United States
Withdrawn
Aarhus N, 8200, Denmark
Withdrawn
Wilmington, 19803, United States
Completed
Minneapolis, 55422, United States
Completed
GENT, 9000, Belgium
Completed
Kromeriz, 767 01, Czechia
Completed
Charleston, 29425, United States
Withdrawn
Jacksonville, 32209, United States
Completed
New Orleans, 70112-1396, United States
Completed
Germantown, 38138, United States
Completed
Stevenage, SG1 4AB, United Kingdom
Withdrawn
Northampton, NN1 5BD, United Kingdom
Completed
Chesterfield, S44 5DX, United Kingdom
Completed
Brisbane, 4029, Australia
Completed
Hobart, 7000, Australia
Withdrawn
Prahran, 3181, Australia
Completed
DARLINGHURST, 2010, Australia
Completed
Ft. Lauderdale, 33308, United States
Completed
Jackson, 39216-4505, United States
Completed
HUY, 4500, Belgium
Completed
Sofia, 1527, Bulgaria
Completed
Saint-Jean-sur-Richelieu, J3A 1C3, Canada
Completed
Montreal, H2W 1T8, Canada
Withdrawn
IEPER, 8900, Belgium
Completed
Sofia, 1202, Bulgaria
Completed
Sofia, 1309, Bulgaria
Completed
Sofia, 1233, Bulgaria
Completed
Stara Zagora, 6000, Bulgaria
Completed
Seoul, 138-736, Korea, Republic Of
Withdrawn
Shanghai, 200025, China
Withdrawn
Frankfurt, 60596, Germany
Completed
Haifa, 3109601, Israel
Completed
Tiberias, 1528001, Israel
Withdrawn
Ureshino, 843-0393, Japan
Withdrawn
Seoul, 06351, Korea, Republic Of
Withdrawn
Seoul, 03722, Korea, Republic Of
Completed
Takamatsu, 760-0018, Japan
Completed
Montreal, H1T 1C8, Canada
Withdrawn
Groningen, 9713 GZ, Netherlands
Completed
Linz, 4020, Austria
Completed
El Palmar, 30120, Spain
Completed
Valencia, 46010, Spain
Completed
Naha, 902-8511, Japan
Completed
Naples, 34102, United States
Completed
Arezzo, 52044, Italy
Completed
Bergamo, 24127, Italy
Completed
Milano, 20149, Italy
Completed
Bad Krozingen, 79189, Germany
Withdrawn
Sofia, 1431, Bulgaria
Completed
Burgas, 8018, Bulgaria
Withdrawn
VELDHOVEN, 5504 DB, Netherlands
Withdrawn
HOORN, 1624 NP, Netherlands
Completed
Redcliffe, 4020, Australia
Completed
Brisbane, 4064, Australia
Withdrawn
Fairfield, 45014, United States
Withdrawn
Liestal, 4410, Switzerland
Completed
BRON Cedex, 69677, France
Completed
Krakow, 31-121, Poland
Completed
Szczecin, 70-965, Poland
Completed
Holbaek, 4300, Denmark
Withdrawn
Slany, 274 01, Czechia
Completed
Hannover, 30625, Germany
Withdrawn
LA TRONCHE, 38700, France
Completed
Linz, 4010, Austria
Completed
Bad Homburg, 61348, Germany
Completed
Randers, 8930, Denmark
Withdrawn
Wien, 1100, Austria
Completed
Chaidari, 12462, Greece
Completed
Athens, 11527, Greece
Completed
Nea Ionia / Athens, 142 33, Greece
Completed
New Taipei City, 220, Taiwan
Withdrawn
Hodmezovasarhely, 6800, Hungary
Completed
Lisboa, 1449-005, Portugal
Completed
Lisboa, 1500-650, Portugal
Completed
Almada, 2801-951, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
Uji, 611-0041, Japan
Withdrawn
Dimitrovgrad, 6400, Bulgaria
Completed
Osaka, 558-8558, Japan
Withdrawn
Toyota, 471-8513, Japan
Withdrawn
Gifu, 500-8717, Japan
Completed
Higashiibaraki, 311-3193, Japan

Primary Outcome

  • Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP)
    date_rangeTime Frame:
    Baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change of left atrial volume (LAV)
    date_rangeTime Frame:
    Baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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