1. Rationale and Design of the EMPA-TROPISM Trial (ATRU-4): Are the "Cardiac Benefits" of Empagliflozin Independent of its Hypoglycemic Activity?
- Author
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Santos-Gallego CG, Garcia-Ropero A, Mancini D, Pinney SP, Contreras JP, Fergus I, Abascal V, Moreno P, Atallah-Lajam F, Tamler R, Lala A, Sanz J, Fuster V, and Badimon JJ
- Subjects
- Benzhydryl Compounds adverse effects, Cardiovascular Agents adverse effects, Double-Blind Method, Exercise Tolerance drug effects, Glucosides adverse effects, Heart Failure diagnosis, Heart Failure physiopathology, Humans, Magnetic Resonance Imaging, New York City, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic, Recovery of Function, Sodium-Glucose Transporter 2 Inhibitors adverse effects, Surveys and Questionnaires, Time Factors, Treatment Outcome, Ventricular Function, Left drug effects, Ventricular Function, Right drug effects, Walk Test, Benzhydryl Compounds therapeutic use, Cardiovascular Agents therapeutic use, Glucosides therapeutic use, Heart Failure drug therapy, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
- Abstract
The SGLT2 inhibitor empagliflozin reduced cardiovascular mortality by 38% and heart failure (HF) hospitalizations by 35% in diabetic patients. We have recently demonstrated the efficacy of empagliflozin in ameliorating HF and improving cardiac function in a non-diabetic porcine model of HF mediated via a switch in myocardial metabolism that enhances cardiac energetics. Therefore, we hypothesized that the cardiac benefits of empagliflozin can also be extended to non-diabetic HF patients. The EMPA-TROPISM clinical trial is a randomized, double-blind, parallel group, placebo-controlled, trial comparing the efficacy of and safety of empagliflozin in non-diabetic HF patients. Eighty patients with stable HF for over 3 months, LVEF < 50%, and New York Heart Association functional class II to IV symptoms will be randomized to empagliflozin 10 mg for 6 months or placebo. All patients will undergo cardiac magnetic resonance (CMR), cardiopulmonary exercise test (CPET), 6-min walk test, and quality of life questionnaires. The primary outcome is the change in left ventricular end-diastolic volume measured by CMR. Secondary end-points include change in peak VO2 (CPET); change in LV mass, in LVEF, in myocardial mechanics (strains), in left atrium volumes, in RV function and volumes, in interstitial myocardial fibrosis, and in epicardial adipose tissue (CMR); change in the distance in the 6-min walk test; and changes in quality of life (Kansas Cardiomyopathy questionnaire [KCCQ-12] and the 36-Item Short Form Survey [SF-36]). Safety issues (e.g., hypoglycemia, urinary infections, ketoacidosis,…) will also be monitored. In summary, EMPA-TROPISM clinical trial will determine whether the SGLT2 inhibitor empagliflozin improves cardiac function and heart failure parameters in non-diabetic HF patients (EMPA-TROPISM [ATRU-4]: Are the "cardiac benefits" of Empagliflozin independent of its hypoglycemic activity; NCT 03485222).
- Published
- 2019
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