Empagliflozin 10 MG
DrugCapsule, once a day for 90 days
Completed
NCT Number: NCT03198585
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction
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).
Completed
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Herlev and Gentofte University Hospital, Copenhagen, Denmark
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
OtherCapsule, once a day for 90 days
Primary outcomes
-
Between-group difference in the change of plasma concentrations of NT-proBNP
Time frame: 90 days
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Morten Schou
Other
Registry information
Official study title
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)
Acronym: Empire HF
Important dates
- Study start
- 2017
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Jun 26, 2017
- Registry last updated
- Feb 5, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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