CompletedPhase 2

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)

United States477 participantsStarted 2013-11-06

Plain-language 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)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

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

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

Timeframe: Baseline, Week 12 (EOT)

Trial details

NCT IDNCT01951638

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08-18

Results submitted2021-01-20

View on ClinicalTrials.gov More Heart Failure trials