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Protocol NumberBAY 1021189 /15829

2013-10-31 - 2015-10-30

Phase II

Terminated5

ICD-10I50.9

Heart failure, unspecified

ICD-9428.9

Heart failure, unspecified

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)

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer AG.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 江福田 Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chern-En Chiang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Tai Kuo Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator WEN-TER Lai Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)

Objectives

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)

Test Drug

BAY 1021189

Active Ingredient

BAY 1021189

Dosage Form

Tablet

Dosage

1.25 mg /2.5 mg /5 mg /10 mg

Endpoints

Primary Outcome Measures :
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.

Other Outcome Measures:
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.

Inclution 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

Exclusion Criteria:

Intravenous inotropes at any time after hospitalization

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    588 participants

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