search
Back to results

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)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (5 mg)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Worsening Heart Failure, Heart Failure with Preserved Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Vericiguat (BAY1021189)(10 mg)

Vericiguat (BAY1021189) (5 mg)

Vericiguat (BAY1021189) (2.5 mg)

Vericiguat (BAY1021189) (1.25 mg)

Placebo

Arm Description

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

2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)

2.5 mg orally once daily for 12 weeks (with sham titrations)

1.25 mg orally once daily for 12 weeks (with sham titrations)

Orally once daily for 12 weeks (with sham titrations)

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
Left atrial volume was measured by echocardiography.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2013
Last Updated
February 25, 2021
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01951638
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2013 (Actual)
Primary Completion Date
August 18, 2015 (Actual)
Study Completion Date
September 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Worsening Heart Failure, Heart Failure with Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat (BAY1021189)(10 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
Vericiguat (BAY1021189) (5 mg)
Arm Type
Experimental
Arm Description
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Arm Title
Vericiguat (BAY1021189) (2.5 mg)
Arm Type
Experimental
Arm Description
2.5 mg orally once daily for 12 weeks (with sham titrations)
Arm Title
Vericiguat (BAY1021189) (1.25 mg)
Arm Type
Experimental
Arm Description
1.25 mg orally once daily for 12 weeks (with sham titrations)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally once daily for 12 weeks (with sham titrations)
Intervention Type
Drug
Intervention Name(s)
Vericiguat (BAY1021189) (1.25 mg)
Intervention Description
1.25 mg BAY1021189 tablets
Intervention Type
Drug
Intervention Name(s)
Vericiguat (BAY1021189) (5 mg)
Intervention Description
5 mg BAY1021189 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Description
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Time Frame
Baseline, Week 12 (end of treatment [EOT])
Title
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
Description
Left atrial volume was measured by echocardiography.
Time Frame
Baseline, Week 12 (EOT)
Other Pre-specified Outcome Measures:
Title
Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description
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.
Time Frame
Baseline, Week 12 (EOT)
Title
Change From Baseline to Week 12 in Heart Rate
Description
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.
Time Frame
Baseline, Week 12 (EOT)
Title
Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
Description
Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.
Time Frame
Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
25056511
Citation
Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Muller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.
Results Reference
background
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

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)

We'll reach out to this number within 24 hrs