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)

Bayer

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Vericiguat (BAY1021189) (5 mg); Drug: Vericiguat (BAY1021189) (1.25 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951638

2013-002288-25 (EudraCT Number)

15829

Details and patient eligibility

About

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)

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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477 participants in 5 patient groups, including a placebo group

Vericiguat (BAY1021189)(10 mg)

Experimental group

Description:

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

Treatment:

Drug: Vericiguat (BAY1021189) (1.25 mg)

Drug: Vericiguat (BAY1021189) (5 mg)

Vericiguat (BAY1021189) (5 mg)

Experimental group

Description:

2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)

Treatment:

Drug: Vericiguat (BAY1021189) (1.25 mg)

Drug: Vericiguat (BAY1021189) (5 mg)

Vericiguat (BAY1021189) (2.5 mg)

Experimental group

Description:

2.5 mg orally once daily for 12 weeks (with sham titrations)

Treatment:

Drug: Vericiguat (BAY1021189) (1.25 mg)

Vericiguat (BAY1021189) (1.25 mg)

Experimental group

Description:

1.25 mg orally once daily for 12 weeks (with sham titrations)

Treatment:

Drug: Vericiguat (BAY1021189) (1.25 mg)

Placebo

Placebo Comparator group

Description:

Orally once daily for 12 weeks (with sham titrations)

Treatment:

Drug: Placebo