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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01951638




Registration number
NCT01951638
Ethics application status
Date submitted
24/09/2013
Date registered
26/09/2013
Date last updated
16/03/2021

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2013-002288-25
Secondary ID [2] 0 0
15829
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vericiguat (BAY1021189) (1.25 mg)
Treatment: Drugs - Vericiguat (BAY1021189) (5 mg)
Treatment: Drugs - 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

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)

Experimental: Vericiguat (BAY1021189) (2.5 mg) - 2.5 mg orally once daily for 12 weeks (with sham titrations)

Experimental: Vericiguat (BAY1021189) (1.25 mg) - 1.25 mg orally once daily for 12 weeks (with sham titrations)

Placebo Comparator: Placebo - Orally once daily for 12 weeks (with sham titrations)


Treatment: Drugs: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets

Treatment: Drugs: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets

Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Timepoint [1] 0 0
Baseline, Week 12 (end of treatment [EOT])
Primary outcome [2] 0 0
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
Timepoint [2] 0 0
Baseline, Week 12 (EOT)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intravenous inotropes at any time after hospitalization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2015
Sample size
Target
Accrual to date
Final
477
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Redcliffe
Recruitment hospital [4] 0 0
- Hobart
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4064 - Brisbane
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment outside Australia
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United States of America
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California
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Florida
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Tennessee
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Wisconsin
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Austria
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Niederösterreich
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Gent
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Gilly
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HUY
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Burgas
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Sofia
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Aalborg
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Toulouse
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Bayern
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Hessen
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Rehovot
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Tel Aviv
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Tiberias
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Zrifin
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Lisboa
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Singapore
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Murcia
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Barcelona
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Valencia
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Helsingborg
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Karlstad
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Linköping
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Stockholm
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Örebro
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Switzerland
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Ticino
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Switzerland
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Genève
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Derbyshire
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United Kingdom
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Hertfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT01951638
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01951638