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A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure

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.
 
ClinicalTrials.gov Identifier: NCT04157751
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective of this study is to assess whether in-hospital administration of empagliflozin results in improvements in heart failure (HF)-related clinical events and patient-reported outcomes (death, heart failure events (HFE) and Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) as a measure of health status (symptoms)) in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial stabilisation.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Empagliflozin Drug: Placebo to Empagliflozin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : June 26, 2021
Estimated Study Completion Date : July 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Empagliflozin Drug: Empagliflozin
Film-coated tablet

Placebo Comparator: Placebo Drug: Placebo to Empagliflozin
Film-coated tablet




Primary Outcome Measures :
  1. The clinical benefit, a composite of death, number of HFE (including HHFs), urgent heart failure visits and unplanned outpatient visits), time to first HFE and change from baseline KCCQ-TSS after 90 days of treatment assessed by the win ratio. [ Time Frame: Baseline and after 90 days of treatment ]
    Hospitalisations for Heart Failure (HHF) Heart Failure Event (HFE) Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)


Secondary Outcome Measures :
  1. Improvement in KCCQ-TSS of ≥ 10 points [ Time Frame: After 90 days of treatment ]
    Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)

  2. Change from baseline in KCCQ-TSS after 90 days of treatment [ Time Frame: Baseline and after 90 days of treatment ]
    Kansas City Cardiomyopathy Questionnaire - Total Symptom Score(KCCQ-TSS)

  3. Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) level over 30 days of treatment (area under the curve (AUC)) [ Time Frame: Baseline and after 30 days of treatment ]
  4. Days alive and out of hospital from study drug initiation until 30 days after initial hospital discharge [ Time Frame: 30 days after initial hospital discharge ]
  5. Days alive and out of hospital from study drug initiation until 90 days after randomisation [ Time Frame: 90 days after randomisation ]
  6. Time to first occurrence of CV death or HFE until end of trial visit [ Time Frame: Up to day 97 ]
  7. Occurrence of HHF until 30 days after initial hospital discharge [ Time Frame: 30 days after initial hospital discharge ]
  8. Occurrence of chronic dialysis or renal transplant or sustained1 reduction of ≥40% eGFR Chronic Kidney Disease Epidemiology Collaboration Equation ((CKD-EPI)cr) [ Time Frame: Up to day 97 ]

    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

  9. Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 15 days of treatment [ Time Frame: After 15 days of treatment ]
  10. Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 30 days of treatment [ Time Frame: After 30 days of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
  • Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
  • Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
  • Patients must fulfil the following stabilisation criteria (while in the hospital):

    • SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
    • no increase in i.v. diuretic dose for 6 hours prior to randomisation,
    • no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
    • no i.v. inotropic drugs for 24 hours prior to randomisation.
  • Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
  • HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
  • Further Inclusion Criteria Apply

Exclusion Criteria:

  • Cardiogenic shock
  • Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
  • Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
  • Below interventions in the past 30 days prior to randomisation or planned during the study:

    • Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
    • All other surgeries that are considered major according to investigator judgement
    • Implantation of cardiac resynchronisation therapy (CRT) device
    • cardiac mechanical support implantation
    • Carotid artery disease revascularisation (stent or surgery)
  • Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
  • Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
  • Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
  • Type 1 Diabetes Mellitus (T1DM)
  • History of ketoacidosis, including diabetic ketoacidosis (DKA)
  • Further Exclusion Criteria Apply

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): NCT04157751


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

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04157751    
Other Study ID Numbers: 1245-0204
2019-002946-19 ( EudraCT Number )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://trials.boehringer-ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs