Status:
COMPLETED
Empagliflozin and Cardiac Remodelling in People Without Diabetes
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Medical and Surgical Knowledge Translation Research Group
Boehringer Ingelheim
Conditions:
Cardiovascular Diseases
Left Ventricular Hypertrophy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effects of empagliflozin on cardiac structure, function and circulating biomarkers in patients with cardiovascular risk factors, but without diabetes. Empa...
Detailed Description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors (empagliflozin, canagliflozin and dapagliflozin) are approved medications to improve glycemic control in adult patients with type 2 diabetes. When add...
Eligibility Criteria
Inclusion
- Female Not of childbearing potential and male subjects ≥ 18 and ≤ 85 years of age (Women Not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause or ≥6 weeks post-surgical bilateral oophorectomy prior to Screening.)
- ≥1 of the major criteria or ≥2 of the minor criteria below:
- Major criteria
- Increased LVMi of ≥96 g/m2 for women and ≥116 g/m2 for men (as calculated by echocardiogram); or LVMi ≥81 g/m2 for women and ≥85 g/m2 for men (as calculated by cMRI)
- ECG evidence of LV hypertrophy (as per the Sokolow-Lyon criteria)
- Structural heart disease defined as interventricular septal thickness or posterior wall thickness at end-diastole of ≥11 mm (as measured by 2D echocardiography or cMRI)
- Persistent hypertension (defined as office blood pressure ≥140/90 mmHg) despite being on ≥3 antihypertensive medications
- Minor criteria
- Prior history of a myocardial infarction (≥3 months ago)
- eGFR ≥30 and ≤60 mL/min/1.73 m2 (as measured by the CKD-EPI formula)
- Body mass index (BMI) ≥27 kg/m2
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
Exclusion
- Female subjects who are pregnant, lactating or of childbearing potential, or are pre-menopausal
- Known type 1 or type 2 diabetes
- Hemoglobin A1C (A1C) ≥6.5%
- eGFR \<30 mL/min/1.73m2
- Known history of severe liver disease (e.g. Child Pugh Class B or C)
- Known history of severe symptomatic untreated anemia in the last 3 months (e.g. hemoglobin \< 90 g/L)
- History of ketoacidosis, or increased chance of developing diabetic ketoacidosis (DKA) e.g. patients who suffer from excessive vomiting, diarrhea, or sweating; subjects who are on a very low carbohydrate diet; or subjects who drink a lot of alcohol.
- Systolic blood pressure \<95mmHg (as measured at the office/clinic visit)
- Subjects in whom coronary revascularization by either percutaneous coronary intervention or bypass surgery is being contemplated within the next 6 months, or who have undergone coronary revascularization in the prior 3 months
- Significant allergy or known intolerance to SGLT2is or any ingredient in the formulations
- Subjects currently experiencing any clinically significant or unstable medical condition that in the opinion of the investigator might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease
- Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
- Subjects who have participated in other interventional studies which may affect any of the primary or secondary outcomes of the study within 30 days of the screening visit
- Contraindications or inability to undergo magnetic resonance imaging such as severe obesity (e.g. weight \>500 lbs) or the presence of metallic fragments, clips, or devices
- Known history of infiltrative cardiomyopathy such as cardiac amyloidosis or cardiac sarcoidosis
- Severe aortic stenosis
- Severe aortic regurgitation
- Severe mitral stenosis
- Severe mitral regurgitation
- Low voltage on ECG limb leads defined by the amplitude of the QRS complex in each limb lead ≤0.5 mV
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04461041
Start Date
April 1 2021
End Date
July 31 2022
Last Update
February 17 2023
Active Locations (4)
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1
Diagnostic Assessment Centre (AMS Diagnostics)
Toronto, Ontario, Canada, M1S 4N6
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
North York Diagnostic and Cardiac Centre
Toronto, Ontario, Canada, M6B 3H7
4
Chang Gung Memorial Hospital
Keelung, Taiwan