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Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

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ClinicalTrials.gov Identifier: NCT01951625
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

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 therapy for heart failure with reduced ejection fraction (HFrEF).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Vericiguat (BAY1021189) (1.25 mg) Drug: Vericiguat (BAY1021189) (5 mg) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 With Reduced Ejection Fraction (HFrEF)
Actual Study Start Date : November 29, 2013
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : June 9, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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

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



Primary Outcome Measures :
  1. Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 [ Time Frame: Baseline, Week 12 ]
    Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure.


Other Outcome Measures:
  1. Changes in Heart Function as Measured by Echocardiography, Left Ventricular End-Diastolic Volume (LVEDV), and Left Ventricular End-Systolic Volume (LVESV) From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    Left Ventricular End-Diastolic Volume (LVEDV) and Left ventricular end-systolic volume (LVESV) are measured echocardiography parameter. These are acquired during a non-invasive echocardiography examination.

  2. Changes in Heart Function as Measured by Echocardiography, Left Ventricular Ejection Fraction (LVEF), From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a noninvasive echocardiography examination. Formula: LVEF = 100*(LVEDV - LVESV)/LVEDV.

  3. Change From Baseline in Systolic and Diastolic Blood Pressure to Week 12 [ Time Frame: Baseline, Week 12 ]
    Blood pressure was measured by monitor measurements after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed.

  4. Change From Baseline in Heart Rate to Week 12 [ Time Frame: Baseline, Week 12 ]
    Heart rate was measured after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed.

  5. Number of Subjects With Clinical Events (Heart Failure [HF] Hospitalization and Cardio-Vascular [CV] Mortality) [ Time Frame: Baseline until 16 weeks ]
    Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.

  6. Number of Subjects With Implantable Cardioverter Defibrillators Cardiac Resynchronization Therapy With Defibrillation (ICD/CRT-D) Therapy [ Time Frame: Baseline upto 16 weeks ]
    ICD / CRT with defibrillation therapy (CRT-D) included previous appropriate interventions such as shocks or anti-tachycardic pacing (ATP) when diagnostic of sustained ventricular tachycardias in pre defined rapid zone.

  7. Number of Subjects With Treatment-Emergent Adverse Events [ Time Frame: From the start of study treatment upto 5 days after the last dose of study drug ]
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; and another medically important serious event as judged by the investigator. AEs are considered to be treatment-emergent if they have started or worsened after first application of study drug up to 5 days after end of treatment with study drug.

  8. Change in Biomarkers From Baseline to Week 12: Osteopontin (ng/mL) [ Time Frame: Baseline, Week 12 ]
  9. Change in Biomarkers From Baseline to Week 12: TIMP-4 (pg/mL) [ Time Frame: Baseline, Week 12 ]
    TIMP-4: tissue inhibitor of matrix metalloproteinases 4

  10. Change in Biomarkers From Baseline to Week 12: cGMP (Pmol/mL) [ Time Frame: Baseline, Week 12 ]
    cGMP: cyclic guanosine monophosphate

  11. Change in Biomarkers From Baseline to Week 12: PIIINP (mcg/L) [ Time Frame: Baseline, Week 12 ]
    PIIINP: pro-collagen III N-terminal peptide

  12. Change in Biomarkers From Baseline to Week 12: GDF-15 (pg/mL) [ Time Frame: Baseline, Week 12 ]
    GDF-15: growth differentiation factor 15

  13. Change in Biomarkers From Baseline to Week 12: ST2 (pg/mL) [ Time Frame: Baseline, Week 12 ]
    ST2: suppression of tumorigenicity 2

  14. Change in Biomarkers From Baseline to Week 12: Gal-3 (μg/mL) [ Time Frame: Baseline, Week 12 ]
    Gal-3: Galectin-3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951625


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01951625    
Other Study ID Numbers: 15371
2013-002287-11 ( EudraCT Number )
First Posted: September 26, 2013    Key Record Dates
Results First Posted: March 25, 2021
Last Update Posted: March 25, 2021
Last Verified: March 2021
Keywords provided by Bayer:
Worsening Heart Failure
Heart Failure with Reduced Ejection Fraction
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases