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)

February 25, 2021 updated by: Bayer

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

477

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Brisbane, Queensland, Australia, 4064
      • Redcliffe, Queensland, Australia, 4020
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1220
      • Wien, Austria, 1090
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
      • Linz, Oberösterreich, Austria, 4020
    • Steiermark
      • Graz, Steiermark, Austria, 8036
  • Belgium
      • Brugge, Belgium, 8000
      • Bruxelles - Brussel, Belgium, 1200
      • Gent, Belgium, 9000
      • Gilly, Belgium, 6060
      • HUY, Belgium, 4500
      • MOL, Belgium, 2400
      • Mechelen, Belgium, 2800
      • Roeselare, Belgium, 8800
  • Bulgaria
      • Burgas, Bulgaria, 8018
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1202
      • Sofia, Bulgaria, 1309
      • Stara Zagora, Bulgaria, 6000
  • Canada
      • Quebec, Canada, G1V 4G5
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2W 1T8
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
      • Sherbrooke, Quebec, Canada, J1G 2E8
  • Czechia
      • Kromeriz, Czechia, 767 01
      • Praha 10, Czechia, 10034
      • Praha 2, Czechia, 12808
      • Praha 4, Czechia, 140 21
      • Praha 6, Czechia, 169 02
  • Denmark
      • Aalborg, Denmark, 9000
      • Holbaek, Denmark, 4300
      • Randers, Denmark, 8930
  • France
      • BRON Cedex, France, 69677
      • Pessac, France, 33604
      • Rouen, France, 76031
      • Toulouse, France, 31403
  • Germany
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
    • Bayern
      • München, Bayern, Germany, 80331
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
  • Greece
      • Athens, Greece, 11527
      • Chaidari, Greece, 12462
      • Nea Ionia / Athens, Greece, 142 33
  • Hungary
      • Budapest, Hungary, 1097
      • Kistarcsa, Hungary, H-2143
      • Szekesfehervar, Hungary, 8000
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7830604
      • Hadera, Israel, 3810101
      • Haifa, Israel, 3109601
      • Jerusalem, Israel, 9103102
      • Petah Tikva, Israel, 4941492
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 6423906
      • Tiberias, Israel, 1528001
      • Zrifin, Israel, 7030000
  • Italy
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Brescia, Lombardia, Italy, 25123
      • Milano, Lombardia, Italy, 20017
      • Milano, Lombardia, Italy, 20149
      • Pavia, Lombardia, Italy, 27100
    • Marche
      • Ancona, Marche, Italy, 60126
    • Toscana
      • Arezzo, Toscana, Italy, 52040
  • Japan
      • Fukui, Japan, 910-8526
      • Hiroshima, Japan, 734-8530
      • Kumamoto, Japan, 862-8505
      • Nagasaki, Japan, 850-8555
      • Osaka, Japan, 558-8558
      • Tokushima, Japan, 770-8539
      • Toyama, Japan, 930-8550
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0981
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3193
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8650
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-0018
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-5188
      • Yokohama, Kanagawa, Japan, 236-0051
      • Yokosuka, Kanagawa, Japan, 238-8567
    • Kyoto
      • Uji, Kyoto, Japan, 611-0041
    • Okinawa
      • Naha, Okinawa, Japan, 902-8511
    • Osaka
      • Sakai, Osaka, Japan, 599-8247
      • Takatsuki, Osaka, Japan, 569-1096
    • Tokushima
      • Komatsushima, Tokushima, Japan, 773-8502
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Minato-ku, Tokyo, Japan, 106-0031
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Heerenveen, Netherlands, 8441 PW
      • Leeuwarden, Netherlands, 8934 AD
      • Sneek, Netherlands, 8601 ZR
  • Poland
      • Bialystok, Poland, 15-276
      • Krakow, Poland, 31-202
      • Krakow, Poland, 31-121
      • Lodz, Poland, 92-213
      • Lodz, Poland, 93-513
      • Olsztyn, Poland, 10-010
      • Poznan, Poland, 61-848
      • Szczecin, Poland, 70-965
  • Portugal
      • Almada, Portugal, 2801-951
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1449-005
      • Lisboa, Portugal, 1500-650
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 169609
      • Singapore, Singapore, 768828
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08023
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
    • Murcia
      • El Palmar, Murcia, Spain, 30120
  • Sweden
      • Helsingborg, Sweden, 251 87
      • Karlstad, Sweden, 652 30
      • Linköping, Sweden, 581 85
      • Stockholm, Sweden, 118 83
      • Örebro, Sweden, 701 85
  • Switzerland
      • Genève, Switzerland, 1205
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • Taiwan
      • Kaohsiung, Taiwan, 813
      • New Taipei City, Taiwan, 220
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10016
      • Taoyuan, Taiwan, 333423
  • United Kingdom
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5DX
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
  • United States
    • California
      • Fountain Valley, California, United States, 92708
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Naples, Florida, United States, 34102
    • Georgia
      • Macon, Georgia, United States, 31201
    • Illinois
      • Chicago, Illinois, United States, 60611-2908
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-1396
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New York
      • Buffalo, New York, United States, 14215
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37232-8802
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (2.5 mg)
2.5 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Placebo Comparator: Placebo
Orally once daily for 12 weeks (with sham titrations)
Drug: Placebo
Experimental: Vericiguat (BAY1021189)(10 mg)
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time Frame: Baseline, Week 12 (end of treatment [EOT])
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Baseline, Week 12 (end of treatment [EOT])
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
Time Frame: Baseline, Week 12 (EOT)
Left atrial volume was measured by echocardiography.
Baseline, Week 12 (EOT)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 12 (EOT)
Blood pressure was measured after at least 10 minutes resting in a sitting position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed.
Baseline, Week 12 (EOT)
Change From Baseline to Week 12 in Heart Rate
Time Frame: Baseline, Week 12 (EOT)
Heart rate was measured after 10 minutes resting in a sitting position (3 measurements taken approximatly 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed.
Baseline, Week 12 (EOT)
Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
Time Frame: Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period
Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.
Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2013

Primary Completion (Actual)

August 18, 2015

Study Completion (Actual)

September 16, 2015

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15829
  • 2013-002288-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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