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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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)

Key facts

Study ID

NCT01951638

Run by

Bayer

People needed

477

Starts

2013-11-06

Expected to finish

2015-09-16

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Intravenous inotropes at any time after hospitalization

Where it is running

• Study site — Fort Lauderdale, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — Newark, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Darlinghurst, New South Wales, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — Redcliffe, Queensland, Australia
• Study site — Hobart, Tasmania, Australia
• Study site — Sankt Pölten, Lower Austria, Austria
• Study site — Graz, Styria, Austria
• Study site — Linz, Upper Austria, Austria
• Study site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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