Chronic Myocardial Injury-Evaluating The Possible Role Of Sodium Glucose Co-Transporter 2 Inhibition (CHIRON)

Phase 2

Active, not recruiting

• Conditions: Chronic Myocardial Injury; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12620001256965
• Lead Sponsor: Flinders University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-24
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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;
10.Recurrent genital infections;
11.Pregnancy or breast-feeding (female), planning to donate sperm (male) or trying to conceive within the next 6 months (males and females);
12.History of allergy to SGLT2 inhibitors or similar drug
13.Concurrent participation in another randomized clinical trial;
14.Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
15.Previous enrolment or randomisation in the present study
16.Currently taking an SGLT2 inhibitor or previous treatment with SGLT2 inhibitor in the last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in high sensitivity troponin T (hs-cTnT) concentration by 6-months.<br><br>All data for in-hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems. Where required, paper medical records will be sought.[ Baseline and 6 months]