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)

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Placebo; Drug: Vericiguat (BAY1021189) (5 mg)

• Registration Number: NCT01951638
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-26
• Study Start: 2013-11-06
• Primary Completion: 2015-08-18
• Study Completion: 2015-09-16
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-10-09
• Disposition First Posted: 2015-11-03
• Results First Submitted: 2021-01-20
• Results First Submitted QC: 2021-01-21
• Status Verified: 2021-02
• Results First Posted: 2021-02-12
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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

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Exclusion Criteria

• Intravenous inotropes at any time after hospitalization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vericiguat (BAY1021189) (5 mg)	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)
Vericiguat (BAY1021189)(10 mg)	Vericiguat (BAY1021189) (1.25 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
Vericiguat (BAY1021189) (2.5 mg)	Vericiguat (BAY1021189) (1.25 mg)	2.5 mg orally once daily for 12 weeks (with sham titrations)
Vericiguat (BAY1021189) (1.25 mg)	Vericiguat (BAY1021189) (1.25 mg)	1.25 mg orally once daily for 12 weeks (with sham titrations)
Vericiguat (BAY1021189)(10 mg)	Vericiguat (BAY1021189) (5 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
Vericiguat (BAY1021189) (5 mg)	Vericiguat (BAY1021189) (1.25 mg)	2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Placebo	Placebo	Orally once daily for 12 weeks (with sham titrations)

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Left Atrial Volume (LAV)	Baseline, Week 12 (EOT)	Left atrial volume was measured by echocardiography.
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	Baseline, Week 12 (end of treatment [EOT])	NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).