Clinical trial NCT01951638: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Worsening Heart Failure
Heart Failure with Preserved Ejection Fraction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
timeFrame: Baseline, Week 12 (end of treatment [EOT])
measure: Change From Baseline to Week 12 in Left Atrial Volume (LAV)
timeFrame: Baseline, Week 12 (EOT)
Secondary outcomes:
Other outcomes:
measure: Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 12 (EOT)
measure: Change From Baseline to Week 12 in Heart Rate
timeFrame: Baseline, Week 12 (EOT)
measure: Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
timeFrame: Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period
Locations:
city: Fountain Valley
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Newark
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Milwaukee
country: United States
state: Wisconsin
city: Darlinghurst
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Brisbane
country: Australia
state: Queensland
city: Redcliffe
country: Australia
state: Queensland
city: Hobart
country: Australia
state: Tasmania
city: St. Pölten
country: Austria
state: Niederösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Brugge
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Gent
country: Belgium
city: Gilly
country: Belgium
city: HUY
country: Belgium
city: Mechelen
country: Belgium
city: MOL
country: Belgium
city: Roeselare
country: Belgium
city: Burgas
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saint-Jean-sur-Richelieu
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Kromeriz
country: Czechia
city: Praha 10
country: Czechia
city: Praha 2
country: Czechia
city: Praha 4
country: Czechia
city: Praha 6
country: Czechia
city: Aalborg
country: Denmark
city: Holbaek
country: Denmark
city: Randers
country: Denmark
city: BRON Cedex
country: France
city: Pessac
country: France
city: Rouen
country: France
city: Toulouse
country: France
city: Bad Krozingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Bad Homburg
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
state: Niedersachsen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Homburg
country: Germany
state: Saarland
city: Erfurt
country: Germany
state: Thüringen
city: Hamburg
country: Germany
city: Athens
country: Greece
city: Chaidari
country: Greece
city: Nea Ionia / Athens
country: Greece
city: Budapest
country: Hungary
city: Kistarcsa
country: Hungary
city: Szekesfehervar
country: Hungary
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Tiberias
country: Israel
city: Zrifin
country: Israel
city: Bergamo
country: Italy
state: Lombardia
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Arezzo
country: Italy
state: Toscana
city: Iizuka
country: Japan
state: Fukuoka
city: Himeji
country: Japan
state: Hyogo
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Takamatsu
country: Japan
state: Kagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Uji
country: Japan
state: Kyoto
city: Naha
country: Japan
state: Okinawa
city: Sakai
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Komatsushima
country: Japan
state: Tokushima
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Fukui
country: Japan
city: Hiroshima
country: Japan
city: Kumamoto
country: Japan
city: Nagasaki
country: Japan
city: Osaka
country: Japan
city: Tokushima
country: Japan
city: Toyama
country: Japan
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Heerenveen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Sneek
country: Netherlands
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Almada
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Santander
country: Spain
state: Cantabria
city: Majadahonda
country: Spain
state: Madrid
city: El Palmar
country: Spain
state: Murcia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Helsingborg
country: Sweden
city: Karlstad
country: Sweden
city: Linköping
country: Sweden
city: Stockholm
country: Sweden
city: Örebro
country: Sweden
city: Lugano
country: Switzerland
state: Ticino
city: Genève
country: Switzerland
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Stevenage
country: United Kingdom
state: Hertfordshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.