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Completed

NCT Number: NCT01951625

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)

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vericiguat (BAY1021189) (1.25 mg)

Drug

1.25 mg BAY1021189 tablets

Vericiguat (BAY1021189) (5 mg)

Drug

5 mg BAY1021189 tablets

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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