Rationale and Design of the EMPA-TROPISM Trial (ATRU-4): Are the “Cardiac Benefits” of Empagliflozin Independent of its Hypoglycemic Activity?

Carlos G. Santos-Gallego, Alvaro Garcia-Ropero, Donna Mancini, Sean P. Pinney, Johanna P. Contreras, Icilma Fergus, Vivian Abascal, Pedro Moreno, Farah Atallah-Lajam, Ronald Tamler, Anu Lala, Javier Sanz, Valentin Fuster, Juan Jose Badimon

Research output: Contribution to journalArticlepeer-review

42 Scopus citations

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).

Original languageEnglish
Pages (from-to)87-95
Number of pages9
JournalCardiovascular Drugs and Therapy
Volume33
Issue number1
DOIs
StatePublished - 15 Feb 2019

Keywords

  • Cardiac magnetic resonance
  • Cardiac remodeling
  • Cardiopulmonary exercise test
  • Diabetes mellitus
  • Empagliflozin
  • Heart failure
  • SGLT2-inhibitors

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