Tofogliflozin mechanism of Action to Retain cardiac function evaluated by (123)I-MIBG scintigraphy, Echocardiography and biomarkers in T2DM patients with Heart Failure

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus with Heart failure; Type 2 diabetes mellitus,Heart failure; D003924

• Registration Number: JPRN-jRCTs041210022
• Lead Sponsor: Murohara Toyoaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Aged >=20 years
2.Diagnosis of type 2 diabetes mellitus and HbA1c of >= 6.5% and =< 10.0%* within 12 weeks before informed consent
*If taking medication for type 2 diabetes since before informed consent,patients whose research physicians determined needed additional type 2 diabetes mellitus drugs were not affected by HbA1c levels.
3.Established documented diagnosis of chronic heart failure NYHA class 2 or 3, for at least 8 weeks prior to informed consent
4.LVEF < 40% within 12 weeks prior to informed consent
5.Sinus rhythm and NT-proBNP >= 125 pg/mL or patients with atrial fibrillation and NT-proBNP >= 365 pg/mL within 12 weeks prior to informed consent
6.eGFR >= 30mL/min/1.73m^2 within 12 weeks prior to informedconsent
7.Signed and dated informed consent

Exclusion Criteria

1.Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to informed consent
2.Receiving therapy with an insulin within 8 weeks prior to informed consent
3.Change in drugs or dosage within 4 weeks prior to informed consent
4.Sympomatic hypotension or systolic blood pressure < 95mmHg
5.History of hospitalization for acute heart failure or heart failure within 4 weeks prior to informed consent
6.History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to informed consent
7.History of PCI, CABG, valvular repair/replacement within 12 weeks prior to informed consent or with plans
8.History of Pacemaker implantation within 12 weeks prior to informed consent or plans
9.Previous cardiac transplantation or with plans
10.Restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy or valvular disease
11.Symptomatic bradycardia
12.Known hypersensitivity to iodine hypersensitivity
13.Receiving therapy with Reserpine,Tricyclic Antidepressants,labetalol
14.Parkinsons disease
15.Malignant tumor in need of treatment
16.Indication of liver disease, defined by serum levels of either ALT, AST above 3 times upper limit of normal, or total bilirubin above 2 times upper limit of normal
17.Severe impaired renal function, defined as eGFR < 30 mL/min/1.73m^2
18.BMI < 18.5 kg/m^2
19.Breastfeeding, pregnant or intent to be pregnant
20.Severe ketosis, diabetic coma or precoma
21.Severe infection, preioperative or serious trauma
22.Known hypersensitivity to tofogliflozin
23.Inappropriate condition for this clinical trial based on the investigators clinical judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified