Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction

Official Title

A Phase III Randomised, 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)

Keywords

Heart Failure Empagliflozin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 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

You CAN'T join if...

  • 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
  • Current use or prior use of a 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

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Merced Vein and Vascular Center accepting new patients
    Merced California 95340 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
ID
NCT03057951
Phase
Phase 3
Study Type
Interventional
Last Updated
June 12, 2018