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 2CompletedNCT01951638

Bayer477 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

477

Conditions

Heart Failure

Interventions

Vericiguat (BAY1021189) (1.25 mg)DRUG

1.25 mg BAY1021189 tablets

Vericiguat (BAY1021189) (5 mg)DRUG

5 mg BAY1021189 tablets

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (158)

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Week 12 (end of treatment [EOT])

Change From Baseline to Week 12 in Left Atrial Volume (LAV)

Left atrial volume was measured by echocardiography.

Time frame: Baseline, Week 12 (EOT)

Data from ClinicalTrials.gov

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Unnamed facility

Fountain Valley, California, United States

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Fort Lauderdale, Florida, United States

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Naples, Florida, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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New Orleans, Louisiana, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Jackson, Mississippi, United States

...and 148 more locations