Phase 2
N=477
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
Bottom Line
View on ClinicalTrials.gov: NCT01951638 ↗Enrolled (actual)
477
Serious AEs
21.7%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) — -0.098; -0.047; 0.071; 0.057 log-transformed picograms per milliliter — p== 0.8991
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vericiguat (BAY1021189) (1.25 mg) (Drug); Vericiguat (BAY1021189) (5 mg) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) |
-0.098; -0.047; 0.071; 0.057; -0.023 | = 0.8991 |
| PRIMARY Change From Baseline to Week 12 in Left Atrial Volume (LAV) |
-3.361; -2.163; -2.142; -1.252; -1.654 | = 0.8156 |
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)
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
Data sourced from ClinicalTrials.gov (NCT01951638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.