None listed
Conditions
Brief summary
While a significant volume of research and resources are devoted to the diagnosis and management of myocardial infarction, chronic myocardial injury represents a far greater proportion of patients with high-sensitivity troponin T threshold above the upper reference limit of >14ng/L. In South Australia almost a third of patients presenting to emergency services have elevated troponin levels, of which approximately 40% are eventually diagnosed with chronic myocardial injury and are associated with greater rates of late cardiovascular deaths and events. Despite the overwhelming burden of chronic cardiac injury, currently no evidence-based recommendations exist for the management of these patients. SGLT-2 inhibitors such as dapagliflozin have shown to reduce heart failure related rehospitalisations and cardiovascular-related mortality among both patients with established diabetes and heart failure as well as patients with heart failure in the absence of diabetes, representing an exciting opportunity to improve the outcomes of patients with cardio-metabolic disease. This study will evaluate the impact of dapagliflozin on the cardiac biomarkers of myocardial injury among patients with chronic cardiac injury.
Interventions
This a double-blind randomised controlled study of a sodium-glucose co-transporter 2 (SGLT2) inhibitor called Dapagliflozin in patients with chronic myocardial injury.
Those enrolled in this study and randomly allocated to the intervention arm will be required to take 10mg of Dapagliflozin orally daily (in the morning) for a total duration of 6 months.
The study aims to enrol 120 participants in total, with the aim of enrolling 90 of these eligible participants in to a sub study. All eligible
This a double-blind randomised controlled study of a sodium-glucose co-transporter 2 (SGLT2) inhibitor called Dapagliflozin in patients with chronic myocardial injury. Those enrolled in this study and randomly allocated to the intervention arm will be required to take 10mg of Dapagliflozin orally daily (in the morning) for a total duration of 6 months. The study aims to enrol 120 participants in total, with the aim of enrolling 90 of these eligible participants in to a sub study. All eligible participants will be offered the opportunity to participant in the sub-study entailing an additional imaging protocol for assessment of outcomes, i.e. Cardiac MRI, until the sub-study number is reached. Cardiac MRIs will be taken pre-enrolment and 6 months post enrolment and the investigation is expected to take approximately 45 minutes. All imaging sessions will be supervised by a cardiologist recognised by the Conjoint Committee for Certification in Cardiac MRI.
Sponsors
Flinders University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed