Evaluation of the effect of Empagliflozin as adjunctive therapy versus placebo on serum level of oxidative stress biomarkers in non-diabetic patients with systolic heart failure: a double-blind randomized clinical trial
To assess the effect of Empagliflozin as adjunctive therapy versus placebo on serum level of oxidative stress biomarkers in non-diabetic patients with systolic heart failure
Design
This is a Phase III double-blind randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Farshchian Heart Hospital in Hamadan city, involving 80 eligible non-diabetic patients with systolic heart failure. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 80 years;
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.
Intervention groups
Intervention group:
Routine treatment plus Empagliflozin 10 mg tablet (manufactured by Abidi Pharmaceutical Co.) daily for 3 months.
Control group:
Routine treatment plus tablet placebo (manufactured by Abidi Pharmaceutical Co.) daily for 3 months
Main outcome variables
Serum levels of oxidative stress factors (malonaldehyde, superoxide dismutase, glutathione peroxidase), serum iron level, serum transferrin level, serum ferritin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N486
Registration date:2023-10-05, 1402/07/13
Registration timing:prospective
Last update:2023-10-05, 1402/07/13
Update count:0
Registration date
2023-10-05, 1402/07/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Empagliflozin as adjunctive therapy versus placebo on serum level of oxidative stress biomarkers in non-diabetic patients with systolic heart failure: a double-blind randomized clinical trial
Public title
Effect of Empagliflozin as adjunctive therapy on serum level of oxidative stress biomarkers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave