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Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction (Empire HF)

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ClinicalTrials.gov Identifier: NCT03198585
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Morten Schou, Herlev and Gentofte Hospital

Brief Summary:

To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.

The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).


Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Drug: Empagliflozin 10 MG Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Empagliflozin 10 mg Drug: Empagliflozin 10 MG
Capsule, once a day for 90 days

Placebo Comparator: Placebo Other: Placebo
Capsule, once a day for 90 days




Primary Outcome Measures :
  1. Between-group difference in the change of plasma concentrations of NT-proBNP [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Between-group difference in the change in daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units [ Time Frame: 90 days ]
  2. Between-group difference in the change in body composition assessed by DXA scan [ Time Frame: 90 days ]
  3. Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance [ Time Frame: 90 days ]
  4. Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin [ Time Frame: 90 days ]
  5. Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test [ Time Frame: 90 days ]
  6. Between-group difference in the change of ketone supply to the heart assessed by blood ketones [ Time Frame: 90 days ]
  7. Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance [ Time Frame: 90 days ]
  8. Between-group difference in the change of uric acid [ Time Frame: 90 days ]
  9. Between-group difference in the change of urine albumin/creatinine ratio [ Time Frame: 90 days ]
  10. Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI [ Time Frame: 90 days ]
  11. Between-group difference in the change of cardiac systolic and diastolic function including left ventricular global longitudinal strain and left ventricular ejection fraction assessed by transthoracic echocardiography at rest and during stress [ Time Frame: 90 days ]
  12. Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including pulmonary capillary wedge pressure to cardiac index ratio [ Time Frame: 90 days ]
  13. Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including left ventricular contractile reserve [ Time Frame: 90 days ]
  14. Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ [ Time Frame: 90 days ]
  15. Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Optimal Heart Failure Therapy in accordance with European and National Guidelines
  • LVEF ≤ 0.40
  • eGFR > 30 ml/min/1.73 m2
  • BMI < 45 kg/m2
  • NYHA class I-III
  • Age > 18 years
  • If T2D - optimal treatment in accordance with European and National Guidelines
  • If T2D - stable doses of antiglycemic treatment for 30 days
  • If T2D - HbA1C 6.5-10%

Exclusion Criteria:

  • CRT-D/-P implanted < 90 days
  • Uncorrected severe valvular disease
  • Non-compliance
  • Use of metalozone
  • NYHA IV
  • Age > 85 years
  • Dementia
  • Admission for HF < 30 days
  • Admission for hypoglycemia < 12 month
  • Known sustained VT
  • Symptomatic hypotension and systolic BP < 95 mmHg
  • Unable to perform an exercise test
  • Immobilization
  • Pregnancy
  • Participation in other medical trials
  • Previous intolerance of Empagliflozin or excipients

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): NCT03198585


Contacts
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Contact: Jesper Jensen, MD +45 38686258 jesper.jensen.06@regionh.dk

Locations
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Denmark
Herlev and Gentofte University Hospital Recruiting
Copenhagen, Denmark, 2730
Contact: Jesper Jensen, MD    +45 38686258    jesper.jensen.06@regionh.dk   
Principal Investigator: Morten Schou, MD         
Sub-Investigator: Jesper Jensen, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Massar Omar, MD    +45 608400609    massar.omar@rsyd.dk   
Principal Investigator: Jacob E Moller, MD         
Sub-Investigator: Massar Omar, MD         
Sponsors and Collaborators
Morten Schou
Investigators
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Principal Investigator: Morten Schou, MD Herlev and Gentofte University Hospital
Principal Investigator: Jacob E Moller, MD Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Morten Schou, MD, PhD, Consultant Cardiologist, Associate Professor, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03198585     History of Changes
Other Study ID Numbers: Empire HF
2017-001341-27 ( EudraCT Number )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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