Heart Failure With Reduced Ejection Fraction
Conditions
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).
Interventions
DRUGEmpagliflozin 10 MG
Capsule, once a day for 90 days
OTHERPlacebo
Capsule, once a day for 90 days
Sponsors
Morten Schou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in the change of plasma concentrations of NT-proBNP | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Between-group difference in the change in body composition assessed by DXA scan | 90 days |
| Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance | 90 days |
| Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin | 90 days |
| Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test | 90 days |
| Between-group difference in the change of ketone supply to the heart assessed by blood ketones | 90 days |
| Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance | 90 days |
| Between-group difference in the change of uric acid | 90 days |
| 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 | 90 days |
| Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI | 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 | 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 | 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 | 90 days |
| Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ | 90 days |
| Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L | 90 days |
| Between-group difference in the change of urine albumin/creatinine ratio | 90 days |
Countries
Denmark
Outcome results
None listed