Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction (EMMY)
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| ClinicalTrials.gov Identifier: NCT03087773 |
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Recruitment Status :
Completed
First Posted : March 23, 2017
Last Update Posted : May 19, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myocardial Infarction | Drug: Empagliflozin 10 mg Drug: Placebo Oral Tablet | Phase 3 |
Type 2 diabetes mellitus (T2DM) is associated with an about two to three-fold increased risk for cardiovascular events as compared to subjects without diabetes.
Sodium-dependent glucose cotransporter 2 (SGLT-2) is mainly expressed in human kidneys and small intestinal cells. In the proximal tubule of the nephron SGLT-2 is responsible for the reabsorption of approximately 90% of the filtrated glucose. Inhibition of SGLT-2 was shown to increase renal glucose excretion and to lower glucose. Subsequently, a number of SGLT-2 inhibitors were developed and are currently approved for the treatment of type 2 diabetes.
Recently, Zinman et al published the results of the EMPA-REG-OUTCOME (Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patient) trial where the cardiovascular impact of a glucose lowering regimen including Empagliflozin as compared to usual glucose control without an SGLT-2 inhibitor was investigated. The trial demonstrated an unexpected reduction in the primary composite endpoint, comprising cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. The reduction was mainly driven by a 38% relative risk reduction in cardiovascular deaths; moreover they demonstrated an impressive 35% relative risk reduction in the secondary endpoint hospitalization for heart failure. Of note, the beneficial effects observed in the Empagliflozin group seem to occur very rapidly after commencing the treatment, as suggested by the early separation of the Kaplan-Meier curves. However, the mechanisms responsible for this finding remain unclear. Diuretic effects with subsequent impact on hemodynamics or potential cardioprotective effects of glucagon, which levels rise under the treatment with SGLT-2 inhibitors and the resulting rise in ketone bodies or a small increase in hematocrit have been suggested.
The aim of our trial is to investigate whether Empagliflozin treatment commenced within 72-h after acute myocardial infarction has an impact on heart failure in subjects with and without diabetes mellitus type 2.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 476 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction |
| Actual Study Start Date : | May 11, 2017 |
| Actual Primary Completion Date : | May 3, 2022 |
| Actual Study Completion Date : | May 17, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Empagliflozin
The subjects will receive Empagliflozin 10mg.
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Drug: Empagliflozin 10 mg
The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.
Other Name: Jardiance |
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Placebo Comparator: Placebo Oral Tablet
The subjects will receive placebo.
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Drug: Placebo Oral Tablet
The subject will receive Placebo orally once daily for 26 weeks.
Other Name: Sugar pill |
- change of nt-proBNP levels [ Time Frame: 26 weeks ]Difference in the change of nt-proBNP levels between treatment groups from randomization to week 26
- changes of ejection fraction [ Time Frame: 26 weeks ]Difference in the change of ejection fraction between treatment groups from randomization to week 26
- changes of ejection fraction [ Time Frame: 6 weeks ]Difference in the change of ejection fraction between treatment groups from randomization to week 6
- changes of left ventricular diastolic function [ Time Frame: 26 weeks ]Difference in the change of left ventricular diastolic function from randomization to week 26
- changes of left ventricular diastolic function [ Time Frame: 6 weeks ]Difference in the change of left ventricular diastolic function from randomization to week 6
- changes of nt-proBNP levels [ Time Frame: 6 weeks ]Difference in the change of nt-proBNP levels between treatment groups from randomization to week 6
- changes of HbA1c [ Time Frame: 26 weeks ]Difference in the change of HbA1c between treatment groups from randomization to week 26 (in subjects with known diabetes mellitus Type 2)
- changes of body weight [ Time Frame: 6 weeks ]Difference in the change of body weight between treatment groups from randomization to week 6
- changes of body weight [ Time Frame: 26 weeks ]Difference in the change of body weight between treatment groups from randomization to week 26
- changes of blood beta-hydroxybutyrate levels [ Time Frame: 6 weeks ]Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 6
- changes of blood beta-hydroxybutyrate levels [ Time Frame: 26 weeks ]Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 26
- number of hospital re-admissions due to heart failure [ Time Frame: 30 weeks ]Difference in the number of hospital re-admissions due to heart failure between the treatment groups
- number of hospital re-admissions for any cause [ Time Frame: 30 weeks ]Difference in the number of hospital re-admissions for any cause between the treatment groups
- duration of hospital stay [ Time Frame: 30 weeks ]Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T-level (or troponin I-level) >10x ULN (upper limit of normal). In addition at least 1 of the following criteria must be the met:
- Symptoms of ischemia
- ECG (electrocardiogram) changes indicative of new ischemia (new ST-T changes or new LBBB)
- Imaging evidence of new regional wall motion abnormality
- 18 - 80 years of age
- Informed consent has to be given in written form
- eGFR (glomerular filtration rate) > 45 ml/min/1.73m2
- Blood pressure before first drug dosing: RR systolic >110 mmHg
- Blood pressure before first drug dosing: RR diastolic >70 mmHg
- ≤72h after myocardial infarction (after the performance of a coronary angiography)
Exclusion Criteria:
- Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
- Blood pH (potential hydrogen) < 7,32
- Known allergy to SGLT-2 inhibitors
- Hemodynamic instability as defined by intravenous administration of catecholamine, calcium sensitizers or phosphodiesterase inhibitors
- >1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea
- Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)
- Acute symptomatic urinary tract infection (UTI) or genital infection
- Patients currently being treated with any SGLT-2 inhibitor or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit
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): NCT03087773
| Austria | |
| Barmherzige Brüder Eisenstadt | |
| Eisenstadt, Burgenland, Austria, 7000 | |
| Klinikum Klagenfurt am Wörthersee | |
| Klagenfurt, Kärnten, Austria, 9020 | |
| Universitätsklinikum St. Pölten | |
| St.Pölten, Niederösterreich, Austria, 3100 | |
| Kepler Universitätsklinikum Linz | |
| Linz, Oberösterreich, Austria, 4021 | |
| Kardinal schwarzenberg Klinikum Schwarzach | |
| Schwarzach Im Pongau, Salzburg, Austria, 5620 | |
| VIVIT Institut am akademischen Lehrkrankenhaus Feldkirch | |
| Feldkirch, Vorarlberg, Austria, 6800 | |
| Landeskrankenhaus Graz II Standort West | |
| Graz, Austria, 8020 | |
| Medical University of Graz | |
| Graz, Austria, 8036 | |
| Uniklinikum Salzburg | |
| Salzburg, Austria, 5020 | |
| Krankenanstalt Rudolfstiftung | |
| Vienna, Austria, 1030 | |
| AKH Vienna | |
| Vienna, Austria, 1090 | |
| Study Director: | Harald Sourij, Assoc.-Prof. | Medical University of Graz | |
| Principal Investigator: | Dirk von Lewinski, Assoc.-Prof. | Medical University of Graz |
| Responsible Party: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT03087773 |
| Other Study ID Numbers: |
HS-2017-01 |
| First Posted: | March 23, 2017 Key Record Dates |
| Last Update Posted: | May 19, 2022 |
| Last Verified: | May 2022 |
| 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 |
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Biomarker Heart failure SGLT-2 inhibitor Empagliflozin Randomized controlled trial |
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Heart Failure Myocardial Infarction Infarction Heart Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Vascular Diseases Empagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |