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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)

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ClinicalTrials.gov Identifier: NCT01951638
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : February 12, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE September 26, 2013
Results First Submitted Date  ICMJE January 20, 2021
Results First Posted Date  ICMJE February 12, 2021
Last Update Posted Date March 16, 2021
Actual Study Start Date  ICMJE November 6, 2013
Actual Primary Completion Date August 18, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2021)
  • 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).
  • Change From Baseline to Week 12 in Left Atrial Volume (LAV) [ Time Frame: Baseline, Week 12 (EOT) ]
    Left atrial volume was measured by echocardiography.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
  • Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline and 12 weeks ]
  • Change of left atrial volume (LAV) [ Time Frame: Baseline and 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 4 months ]
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2021)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Vericiguat (BAY1021189) (1.25 mg)
    1.25 mg BAY1021189 tablets
  • Drug: Vericiguat (BAY1021189) (5 mg)
    5 mg BAY1021189 tablets
  • Drug: Placebo
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Vericiguat (BAY1021189) (1.25 mg)
    • Drug: Vericiguat (BAY1021189) (5 mg)
  • 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)
    Interventions:
    • Drug: Vericiguat (BAY1021189) (1.25 mg)
    • Drug: Vericiguat (BAY1021189) (5 mg)
  • Experimental: Vericiguat (BAY1021189) (2.5 mg)
    2.5 mg orally once daily for 12 weeks (with sham titrations)
    Intervention: Drug: Vericiguat (BAY1021189) (1.25 mg)
  • Experimental: Vericiguat (BAY1021189) (1.25 mg)
    1.25 mg orally once daily for 12 weeks (with sham titrations)
    Intervention: Drug: Vericiguat (BAY1021189) (1.25 mg)
  • Placebo Comparator: Placebo
    Orally once daily for 12 weeks (with sham titrations)
    Intervention: Drug: Placebo
Publications * Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2015)
477
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
470
Actual Study Completion Date  ICMJE September 16, 2015
Actual Primary Completion Date August 18, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries China,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01951638
Other Study ID Numbers  ICMJE 15829
2013-002288-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP