Trial record 1 of 1 for:
NCT03198585
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction (Empire HF)
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| ClinicalTrials.gov Identifier: NCT03198585 |
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Recruitment Status :
Completed
First Posted : June 26, 2017
Last Update Posted : February 5, 2020
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Sponsor:
Morten Schou
Information provided by (Responsible Party):
Morten Schou, Herlev and Gentofte Hospital
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 190 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 |
| Actual Primary Completion Date : | December 20, 2019 |
| Actual Study Completion Date : | January 17, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Empagliflozin
| 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 :
- Between-group difference in the change of plasma concentrations of NT-proBNP [ Time Frame: 90 days ]
Secondary Outcome Measures :
- 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 ]
- Between-group difference in the change in body composition assessed by DXA scan [ Time Frame: 90 days ]
- Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance [ Time Frame: 90 days ]
- Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin [ Time Frame: 90 days ]
- Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test [ Time Frame: 90 days ]
- Between-group difference in the change of ketone supply to the heart assessed by blood ketones [ Time Frame: 90 days ]
- Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance [ Time Frame: 90 days ]
- Between-group difference in the change of uric acid [ Time Frame: 90 days ]
- Between-group difference in the change of urine albumin/creatinine ratio [ Time Frame: 90 days ]
- Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI [ Time Frame: 90 days ]
- 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 ]
- 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 ]
- 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 ]
- Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ [ Time Frame: 90 days ]
- 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
Locations
| Denmark | |
| Herlev and Gentofte University Hospital | |
| Copenhagen, Denmark, 2730 | |
| Odense University Hospital | |
| Odense, Denmark, 5000 | |
Sponsors and Collaborators
Morten Schou
Investigators
| 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):
| Responsible Party: | Morten Schou, MD, PhD, Consultant Cardiologist, Associate Professor, Herlev and Gentofte Hospital |
| ClinicalTrials.gov Identifier: | NCT03198585 |
| Other Study ID Numbers: |
Empire HF 2017-001341-27 ( EudraCT Number ) |
| First Posted: | June 26, 2017 Key Record Dates |
| Last Update Posted: | February 5, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |