Chronic Myocardial Injury-Evaluating The Possible Role Of SGLT-2 Inhibition. A phase II multicentre double blind randomised parallel group comparison of 10mg dapagliflozin versus placebo over 6 months in chronic myocardial injury

Flinders University of South Australia0 sites30 target enrollmentNovember 24, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 24, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Flinders University of South Australia

•Patients will be considered eligible if they meet all of the following:
•1\. Chronic elevation of defined as a troponin T velocity of \<3ng/L/hour assessed with at least 3 troponin values measued, with at least 2 of these being 4 hours apart, AND with at least 1 of these values \>14ng/L, within the first 24 hours of initial presentation;
•2\. Age of 18 years or older;
•3\. Willing to give informed consent

•Patients will be considered ineligible if they meet any of the following:
•1\.Troponin T: Maximal in hospital troponin level \>100ng/L within the first 24 hours of initial presentation or acute myocardial injury, defined as a rise and/or fall in troponin T with a velocity of \>3ng/L/hr;
•2\.Recent coronary revascularization (PCI and CABG) within the last 6 months
•3\.Active heart failure with clinical symptoms of dyspnoea or extra\-vascular volume overload and a NT\-proBNP level \>500ng/L;
•4\.Treated diabetes, defined as receiving any long\-term/chronic oral or parenteral pharmacotherapies for the treatment of established diabetes;
•5\.Renal impairment with a documented eGFR of \<45ml/min/1\.73m2;
•6\.Documented HBA1C level \>7% in the previous 3 months;
•7\.Presentation with documented ST segment elevation on ECG representing either ST\-segment elevation MI or pericarditis;
•8\.Documented pulmonary embolus or aortic dissection;
•9\.History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time;