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EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

This study is currently recruiting participants.
Verified November 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT03057951
First Posted: February 20, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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

Condition Intervention Phase
Heart Failure Drug: Empagliflozin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with preserved Ejection Fraction (HFpEF) [ Time Frame: up to 38 months ]
    Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with preserved Ejection Fraction (HFpEF)


Secondary Outcome Measures:
  • Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent) [ Time Frame: up to 38 months ]
    Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent)

  • eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr slope of change from baseline [ Time Frame: up to 38 months ]
    eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr slope of change from baseline

  • Time to first occurrence of sustained reduction of eGFR [ Time Frame: up to 38 months ]

    Time to first occurrence of sustained reduction of >= 40% eGFR (CKD-EPI)cr or

    • sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for patients with baseline eGFR >=30 mL/min/1.73 m2
    • sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30 mL/min/1.73 m2

  • Time to first adjudicated HHF (Hospitalisation for Heart Failure) [ Time Frame: up to 38 months ]
    Time to first adjudicated HHF (Hospitalisation for Heart Failure)

  • Time to adjudicated CV (Cardiovascular) death [ Time Frame: up to 38 months ]
    Time to adjudicated CV (Cardiovascular) death

  • Time to all-cause mortality [ Time Frame: up to 38 months ]
    Time to all-cause mortality

  • Time to onset of DM (Diabetes Mellitus) [ Time Frame: up to 38 months ]
    Time to onset of DM (Diabetes Mellitus)

  • Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at week 52

  • Occurrence of all-cause hospitalisation (first and recurrent) [ Time Frame: up to 38 months ]
    Occurrence of all-cause hospitalisation (first and recurrent)


Estimated Enrollment: 4126
Actual Study Start Date: March 2, 2017
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Empagliflozin Drug: Empagliflozin
once daily
Placebo Comparator: Placebo Drug: Placebo
once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057951


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 308 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03057951     History of Changes
Other Study ID Numbers: 1245.110
First Submitted: February 16, 2017
First Posted: February 20, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs