Patients with type 2 diabetes mellitus and heart failure of ischemic origin
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Film-coate
Sponsors
Karolinska Institutet Stockholm, Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Known T2DM (according to current WHO criteria) with HbA1c 48-86 mmol/mol (DCCT 5.6-10%; [57]). 3. Chronic HF of ischemic origin (established according to current European Guidelines; Ischemic etiology defined as history of myocardial infarction given by typical ECG-changes (Q-wave or LBBB), previous PCI or CABG, symptoms typical of angina pectoris with coronary artery disease verified by an exercise test, non-invasive imaging or coronary angiography, since at least two months [58]. 4. Signed informed consent to trial participation consistent with ICH-GCP guidelines and local legislations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Age > 75 years 2. Contraindications to magnetic resonance imaging a) Implanted devices such as pacemaker or implantable cardioverter defibrillator b) Severe claustrophobia 3. Serum creatinine estimated glomerular filtration rate 60% of expected normal value and the reversibility test result should be <10% of the initial FEV1.0 value. 5. Patients with severe concomitant disease (i.e. malignancy, liver failure) or chronic HF due to valvular disorders. 6. Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: problems to self-monitor glucose, linguistic problems, resident outside of the catchment area, alcohol or drug abuse, psychiatric disorder) 7. Planned for intervention with at discharge are planned for Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention or cardiac device treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that empagliflozin (Jardiance™) 25 mg once daily for four months improves myocardial function, structure and coronary flow reserve measured by means of cardiac magnetic resonance in patients with T2DM and HF of ischemic origin. ;Secondary Objective: Not applicable;Primary end point(s): Primary endpoints are 1. Improvement in LV systolic and diastolic function (an increase in LV ejection fraction, a reduction in LV filling pressures and a decrease in the LV end diastolic volume) measured by cardiovascular magnetic resonance (CMR) and echocardiography 2. An increase in coronary flow reserve measured by rest/adenosine coronary sinus phase contrast flow and rest/adenosine quantitative first pass myocardial perfusion 3. Decrease in the left ventricular end-diastolic volume and myocardial extracellular volume (ECV) ;Timepoint(s) of evaluation of this end point: After 4 months on active treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Reduction in the NT-pro BNP levels 2. Changes in blood volume evaluated by Hematocrit, Hb and radiolabelled albumin 3. Improvement in endothelial function 4. Decrease in arterial stiffness 5. Reduction of expressions of inflammatory activation and oxidative stress 6. Hospitalizations for HF ;Timepoint(s) of evaluation of this end point: After 4 months on active treatment | — |
Countries
Sweden
Contacts
Public ContactDepartment of Medicine Solna
Cardiology Unit
Outcome results
None listed