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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

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)

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 : 477 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 and Preserved Ejection Fraction (HFpEF)
Actual Study Start Date : November 6, 2013
Actual Primary Completion Date : August 18, 2015
Actual Study Completion Date : September 16, 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 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).

  2. Change From Baseline to Week 12 in Left Atrial Volume (LAV) [ Time Frame: Baseline, Week 12 (EOT) ]
    Left atrial volume was measured by echocardiography.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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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): NCT01951638


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01951638    
Other Study ID Numbers: 15829
2013-002288-25 ( EudraCT Number )
First Posted: September 26, 2013    Key Record Dates
Results First Posted: February 12, 2021
Last Update Posted: March 16, 2021
Last Verified: February 2021
Keywords provided by Bayer:
Worsening Heart Failure
Heart Failure with Preserved Ejection Fraction
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases