The effect of tofogliflozin on myocardial fibrosis

Not Applicable

Recruiting

• Conditions: type 2 diabetes with nonalcoholic fatty liver disease at risk for heart failure

• Registration Number: JPRN-jRCTs051220140
• Lead Sponsor: oguchi Michio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1 Patients aged >= 20 and < 85 years at the provision of written informed consent
2 Patients with type 2 diabetes mellitus
patients who need a new drug or the change of drugs for type 2 diabetes mellitus
patients who are possible to change drugs for type 2 diabetes mellitus
3 Patients with nonalcoholic fatty liver disease
4 Patients who have at least one of the following risks of heart failure: Established cardiovascular disease, LV hypertrophy, LA enlargement and E/e' > 9
5 Patients with HbA1c 10% or less
6 Patients with written informed consent

Exclusion Criteria

1 eGFR < 45 ml/min/1.73 m2 at screening
2 Patients with chronic heart failure NYHA class II-IV and reduced ejection fraction (LVEF <= 40 %)
3 Patients with suspected severe liver fibrosis
4 Patients with acute myocardial infarction, ampulla cardiomyopathy and acute myocarditis in the prior 24 weeks
5 Patients who have underwent coronary revascularization by PCI or bypass surgery in the prior 8 weeks
6 Patients in whom coronary revascularization is being contemplated within 24 weeks
7 Diagnosed cardiac amyloidosis
8 Diagnosed persistent atrial fibrillation
9 Patients who have underwent valve replacement surgery, pacemaker implantation including cardiac resynchronization therapy or ICD implantation
10 Conditions preventing safe contrast-enhanced MRI imaging
11 Patients with contraindication to tofogliflozin
12 Patients treated with SGLT2 inhibitors within 12 weeks
13 Diagnosed idiopathic pulmonary fibrosis
14 Diagnosed malignant tumors
15 Female who are pregnant, breast-feeding, or may be pregnant
16 Subjects who have participated or plan to participate in another clinical research
17 Patients who were judged by the investigator to be inappropriate for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in indexed extracellular volume (iECV) from baseline to 24 weeks

Secondary Outcome Measures

Name	Time	Method
1 Changes in LVMi (MRI) from baseline to 24 weeks<br>2 Changes in Indexed cell volume (MRI) from baseline to 24 weeks<br>3 Changes in ECVf (MRI) from baseline to 24 weeks<br>4 Changes in Native T1 value (MRI) from baseline to 24 weeks<br>5 Changes in LV end-diastolic volume and end-sysytolic volume (MRI) from baseline to 24 weeks<br>6 Changes in RV end-diastolic volume and end-sysytolic volume (MRI) from baseline to 24 weeks<br>7 Changes in LVEF (MRI) from baseline to 24 weeks<br>8 Changes in RVEF (MRI) from baseline to 24 weeks<br>9 Changes in LVM/LVEDV (MRI) from baseline to 24 weeks<br>10 Changes in E/e' (echocardiography) from baseline to 24 weeks<br>11 Changes in AST, ALT, GGT from baseline to 12, 24 weeks<br>12 Changes in FIB4 index from baseline to 12, 24 weeks<br>13 Changes in HbA1c from baseline to 12, 24 weeks<br>14 Changes in body weight from baseline to 12, 24 weeks<br>15 Changes in blood pressure (systolic diastolic and mean) from baseline to 12, 24 weeks