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)

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951638
• Other study ID #: 15829
• Secondary ID: 2013-002288-25
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2013
• Est. completion date: September 16, 2015

Study information

• Verified date: February 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: September 16, 2015
• Est. primary completion date: August 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
• Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (1)

Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	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.	Baseline, Week 12 (EOT)
Other	Change From Baseline to Week 12 in Heart Rate	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.	Baseline, Week 12 (EOT)
Other	Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)	Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.	Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period
Primary	Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).	Baseline, Week 12 (end of treatment [EOT])
Primary	Change From Baseline to Week 12 in Left Atrial Volume (LAV)	Left atrial volume was measured by echocardiography.	Baseline, Week 12 (EOT)

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