Protocol summary

Study aim
Evaluating the effect of empagliflozin on blood pressure, cardiovascular events, mortality and renal parameters in patients undergoing coronary artery bypass surgery
Design
Double-blind, randomized, placebo-controlled clinical
Settings and conduct
This study will be conducted in the intensive care unit of Afshar Hospital in Yazd. The patients will be divided into two groups receiving Empagliflozin tablet and placebo by random permutation block method. Each patient will be identified with a number and the list of numbers of people who should be placed in each group will be given to the nurses and the participants, researchers, doctors And the data collectors will be unaware of this list.
Participants/Inclusion and exclusion criteria
Input criteria include:Patients undergoing coronary artery bypass surgery Not being allergic to empagliflozin Exclusion criteria include:Patients who cannot get enough information with echocardiography History of taking pioglitazone at least 8 weeks before entering the study Glomerular filtration rate less than 30 mg per minute per 1.73 square meters of body surface based on the CKD-EPI formula Pregnant or lactating women
Intervention groups
intervention group: Recipients of empagliflozin 10 mg tablets from Abidi Pharmaceutical Company receive one empagliflozin tablet orally a few hours after coronary artery bypass surgery to reduce blood pressure, cardiovascular events, mortality, and control kidney parameters control group: The recipients of a placebo prepared in the pharmaceutical laboratory of the Yazd Faculty of Pharmacy in the same size and color as the empagliflozin tablet, a few hours after coronary bypass surgery, take a 10 mg tablet orally to reduce blood pressure, cardiovascular events, mortality and Renal controls
Main outcome variables
The rate of reduction of blood pressure, cardiovascular events, mortality and control of renal parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190911044744N3
Registration date: 2023-12-03, 1402/09/12
Registration timing: prospective

Last update: 2023-12-03, 1402/09/12
Update count: 0
Registration date
2023-12-03, 1402/09/12
Registrant information
Name
Ehsan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 5885
Email address
ehsan.mirzaei.1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of empagliflozin on blood pressure, cardiovascular events, mortality and renal parameters in patients undergoing coronary artery bypass surgery admitted to the A coronary care unit
Public title
Effect of empagliflozin on blood pressure, cardiovascular events, mortality and renal parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing coronary artery bypass surgery Not being allergic to empagliflozin
Exclusion criteria:
Patients who cannot get enough information with echocardiography History of taking pioglitazone at least 8 weeks before entering the study Glomerular filtration rate less than 30 mg per minute per 1.73 square meters of body surface based on the CKD-EPI formula Pregnant or lactating women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided into 25-person groups.using the statistical software,25 out of 50 patients are randomly assigned to treatment group and 25 to placebo group. Unit of randomization: lndividual. Tools used in randomization:computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug or placebo , are determined by numbers and these numbers are given to the head nurse and nurses of surgery department.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Faculty of Pharmacy,Yazd, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.139

Health conditions studied

1

Description of health condition studied
Patients undergoing coronary artery bypass surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft

Primary outcomes

1

Description
Reduction of blood pressure
Timepoint
Daily
Method of measurement
Mercury pressure gauge

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Recipients of empagliflozin 10 mg tablets from Abidi Pharmaceutical Company receive one empagliflozin tablet orally a few hours after coronary artery bypass surgery to reduce blood pressure, cardiovascular events, mortality, and control kidney parameters
Category
Treatment - Drugs

2

Description
Control group: The recipients of a placebo prepared in the pharmaceutical laboratory of the Yazd Faculty of Pharmacy in the same size and color as the empagliflozin tablet, a few hours after coronary bypass surgery, take a 10 mg tablet orally to reduce blood pressure, cardiovascular events, mortality and Renal controls
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Ehsan Mirzaei
Street address
Yazd-Jomhouri Blvd
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۹۴۵۵۵۶
Phone
+98 35 3525 5011
Email
ehsan.mirzaei.1369@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parisa Naseri
Street address
Faculty of pharmacy, Yazd, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 936 850 6994
Email
Parisa2473@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of Pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parisa Naseri
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of pharmacy, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...