Conditions: Heart Failure
Keywords: Worsening Heart Failure Heart Failure with Reduced Ejection Fraction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 456
Healthy volunteers: no

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 therapy for heart failure with reduced ejection fraction (HFrEF).

Detailed description:

Arms:
arm 1: 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 arm 2: 2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration) arm 3: 2.5 mg orally once daily for 12 weeks (with sham titrations) arm 4: 1.25 mg orally once daily for 12 weeks (with sham titrations) arm 5: Orally once daily for 12 weeks (with sham titrations)

Interventions: intervention 1: Vericiguat (BAY1021189) (1.25 mg) intervention 2: Vericiguat (BAY1021189) (5 mg) intervention 3: Placebo
Intervention descriptions: intervention 1: 1.25 mg BAY1021189 tablets intervention 2: 5 mg BAY1021189 tablets intervention 3: None

Protocol document: