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Completed

NCT Number: NCT01951638

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)

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)

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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

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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 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 outcomes

  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.

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 and Preserved Ejection Fraction (HFpEF)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Mar 16, 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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