Validation of ERTugliflozin for Inhibiting Cardiac Fibros... | NCT04490681

Status Module

Description Module

Label	Type	Description	Intervention Names
Ertugliflozin	Experimental	Ertugliflozin 5mg	Drug: Ertugliflozin
placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ertugliflozin	Drug	Fixed dose Ertugliflozin (5mg)	Ertugliflozin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration	The ECV value change in MRI from baseline to End of trial (48 weeks)	Baseline
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration	The ECV value change in MRI from baseline to End of trial (48 weeks)	48 Weeks after drug administration

Secondary Outcomes

Measure	Description	Time Frame
CMR parameters : ECV (%)	CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must agree to the study protocol and provide written informed consent
Outpatients ≥ 19 years, <75 years of age, male or female
Non-diabetic or type 2 DM patients with HbA1c 7.0-10.5%
Patients with nonischemic cardiomyopathy (LVEF ≤40%)
Exclusion of ischemic origin cardiomyopathy using coronary angiography or CT angiography or SPECT scan (e.g. significant stenosis of proximal LAD or left main & myocardial infarction)
Dyspnea of NYHA functional class II or III
NT-proBNP ≥ 400 pg/ml (≥ 900 pg/ml if atrial fibrillation or atrial flutter)
Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB or ARNI if indicated) for at least 4 weeks prior to study entry

Exclusion Criteria:

History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or SGLT-2 as well as known or suspected contraindications to the study drug
Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
Known history of angioedema
Current acute decompensated heart failure or dyspnea of NYHA functional class IV
Medical history of hospitalization within 6 weeks
Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
Substantial myocardial ischemia requiring coronary revascularization therapy or a plan of coronary revascularization within 6 months
A plan of heart transplantation or implantation of cardiac resynchronization therapy
Symptomatic hypotension and/or a SBP < 95 mmHg at screening
Estimated GFR < 30 mL/min/1.73m2
History of ketoacidosis
Symptomatic peripheral artery disease and history of lower limb amputation
Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt.
History of severe pulmonary disease
Significant mitral & aortic valve disease (e.g. moderate to severe, severe degree)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method
Pregnant or nursing (lactating) women
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study