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

Effect of Empagliflozin as adjunctive therapy versus placebo on serum level of oxidative stress biomarkers in diabetic patients with systolic heart failure: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N484

Enrollment

Registered

2023-09-30

Start date

2023-10-23

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic heart failure. Systolic (congestive) heart failure

Interventions

Intervention 1: Intervention group: Routine treatment plus tablet Empagliflozin 10 mg (manufactured by Abidi Pharmaceutical Co.) daily for 3 months. Intervention 2: Control group: Routine treatment pl

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahmi Hassan Saleh

Hamedan University of Medical Sciences

fahmihassan1972@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026