Effect of Empagliflozin as adjunctive therapy versus placebo on serum level of oxidative stress biomarkers in diabetic patients with systolic heart failure

Phase 3

• Conditions: Systolic heart failure.; Systolic (congestive) heart failure; I50.2

• Registration Number: IRCT20120215009014N484
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age 18 to 80 years
Type 2 diabetes
Controlled systolic heart failure for at least 6 months
Hemoglobin A1c less than 6.5
Stable clinical and hemodynamic status

Exclusion Criteria

Pregnancy or breastfeeding
Inflammatory, respiratory, infectious or malignant diseases
History of myocardial infarction, stroke, angioplasty or CABG in the last 3 months
Embedding pacemaker in the last 3 months
Use of anti-oxidant or anti-inflammatory drugs or corticosteroids in the last 3 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of oxidative stress factors (malonaldehyde, superoxide dismutase, glutathione peroxidase). Timepoint: Before the intervention and 3 months later. Method of measurement: By blood sample testing.;Serum iron level. Timepoint: Before the intervention and 3 months later. Method of measurement: By blood sample testing.;Serum transferrin level. Timepoint: Before the intervention and 3 months later. Method of measurement: By blood sample testing.;Serum ferritin level. Timepoint: Before the intervention and 3 months later. Method of measurement: By blood sample testing.