SGLT2 Inhibition in Patients With Type 2 Diabetes Mellitus and Acute Decompensated Heart Failure: SLIM-AHF Study

Phase 4

• Conditions: acute decompensated heart failure complicated with type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000026315
• Lead Sponsor: Osaka General Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-27
• Study Completion: 2020-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with severe primary valvular heart disease 2) Patients with acute coronary syndrome 3) Patients with heart transplantation 4) Patients who do not need diuretic therapy because of dehydration 5) Patients with cardiogenic shock at eligibility qualification 6) Patients with intubation and mechanical ventilation at eligibility qualification 7) Patients who need mechanical circulatory assist device (IABP, PCPS) at eligibility qualification 8) Patients with myocarditis 9) Patients with hypertrophic obstructive cardiomyopathy 10) Patients with type 1 diabetes mellitus 11) Patients with reduced endogenous insulin secretion (fasting C-peptide level <1.0 ng/mL) 12) Patients who had already been on SGLT2 inhibitors 13) Patients with severe diabetic ketoacidosis or diabetic coma 14) Patients with a history of hypersensitivity reaction to empagliflozin 15) Patients who cannot have diet or receive enteral nutrition therapy within 96 hours of admission 16) Patients who are pre or post surgery, or patients with severe infection or serious trauma 17) Patients whose life expectancy is less than 6 months due to extracardiac disease 18) Patients with severe renal dysfunction (estimated glomerular filtration rate <15mL/min/1.73m2) or those with dialysis 19) Patients with a history of acute coronary syndrome, stroke or transient ischemic attack within one month of eligibility qualification 20) Pregnant, possibly pregnant or lactating women 21) Patients who were judged inappropriate by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified