A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Save

Date Added
January 3rd, 2018
PRO Number
Pro00065220
Researcher
Ryan Macnevin
Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.

Inclusion criteria:
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply

Exclusion criteria:
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply

Institution
Palmetto
Recruitment Contact
Ryan MacNevin
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

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