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
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Worsening Heart Failure, Heart Failure with Preserved Ejection Fraction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Vericiguat (BAY1021189)(10 mg)
Vericiguat (BAY1021189) (5 mg)
Vericiguat (BAY1021189) (2.5 mg)
Vericiguat (BAY1021189) (1.25 mg)
Placebo
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
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
2.5 mg orally once daily for 12 weeks (with sham titrations)
1.25 mg orally once daily for 12 weeks (with sham titrations)
Orally once daily for 12 weeks (with sham titrations)