Comparison of the effect of oral empagliflozin and placebo on cardiovascular function and quality of life in patients with acute myocardial infarction: a randomized, double-blind clinical trial.
This research aims to determine the effect of empagliflozin on clinical, echocardiographic, and laboratory findings in patients with acute myocardial infarction.
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized by random numbers table, phase 2 on 354 patients.
Settings and conduct
This research is a double-blind clinical trial study, which will be conducted in Hamedan Farshchian Heart and Vascular Hospital.
In order to make the study blind (double-blind), the medicine of the patients in the two intervention and control groups, with the coordination of the pharmacy, is poured into capsules of the same color and size and delivered to the researcher with a numerical code (1 and 2). This numerical code is hidden from the researcher and patient and will be revealed only after research and data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of ST elevation MI;
Glomerular filtration rate (rGFR) more than 30;
Systolic blood pressure before the first dose of the drug more than 110;
Diastolic blood pressure before the first dose of medicine more than 70;
The first dose of drug administration is less than 72 hours after the occurrence of an acute stroke.
Exclusion criteria:
DM other than type2;
History of diabetic ketoacidosis;
Hemodynamic instability;
urinary tract infection;
treatment with SGLT2 inhibitors.
Intervention groups
Intervention group: With the coordination of an internist, patients receive empagliflozin at a dose of 10 mg per day (single dose) for 3-5 days.
Control group: During this period, the patients in the placebo group will receive a placebo, which is composed of starch compounds and without side effects, and it will be the same amount of 10 mg once a day.
Main outcome variables
Quality of life, cardiovascular function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230501058035N2
Registration date:2023-09-23, 1402/07/01
Registration timing:registered_while_recruiting
Last update:2023-09-23, 1402/07/01
Update count:0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Ramin Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 013 1815
Email address
raminmn4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral empagliflozin and placebo on cardiovascular function and quality of life in patients with acute myocardial infarction: a randomized, double-blind clinical trial.
Public title
The effectiveness of empagliflozin in patients with acute myocardial infarction
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ST elevation MI acute myocardial infarction by a cardiologist based on clinical variables and ECG
Glomerular filtration rate (rGFR) more than 30
Systolic blood pressure before the first dose of the drug more than 110
Diastolic blood pressure before the first dose of medicine more than 70
The first dose of drug administration less than 72 hours after the occurrence of an acute stroke
Exclusion criteria:
People with diabetes other than type 2
History of diabetic ketoacidosis
Hemodynamic instability caused by intravenous administration of catecholamine, calcium sensitizers, or phosphodiesterase inhibitors
Acute symptomatic urinary tract infection
Genital infection
Continuous treatment with SGLT2 inhibitors
Being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) four weeks before the screening visit.
Known allergy to SGLT-2 inhibitors
Severe hypoglycemia in the last six months treated with insulin or sulfonylurea
Symptomatic acute urinary tract infection (UTI) or genital infection
Patients currently receiving treatment with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin).
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
354
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be done as a simple randomization, using a table of random numbers.
In this method, the study members are numbered from 001 to N, then a row and a column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. From this point, a plus or a cross is drawn. All the numbers on the plus or cross are selected as members of the sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
To make the study blind (double-blind), the medicine of the patients in the two intervention and control groups, with the coordination of the pharmacy, is poured into similar capsules in terms of color and size and delivered to the researcher with a numerical code (1 and 2). This numerical code is hidden from the researcher and patient and will be revealed only after research and data analysis.
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
No 5, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.276
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I22.9
ICD-10 code description
Subsequent ST elevation (STEMI) myocardial infarction of unspecified site
Primary outcomes
1
Description
Cardiovascular function in echocardiography
Timepoint
The systolic and diastolic function of the left ventricle of the heart is measured in two stages (before the intervention and then 4 to 6 weeks after discharge from the hospital).
Method of measurement
Using an echocardiography device using the Simpson method
2
Description
Quality of life with SF36 questioner
Timepoint
Before and after interventions
Method of measurement
SF36 questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Medical intervention with EMPAGLIFLOZIN KHARAZMI 10 MG Tablet per day (single dose) for 3-5 days.
Category
Treatment - Drugs
2
Description
Control group: The patients in the placebo group will receive that the composition is starch compounds without side effects and it will be the same amount of 10 mg once a day for 3-5 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Cardiology subspecialty medical center
Full name of responsible person
Amirhossein Yazdi
Street address
Shahid Fahmideh Ave., Pazhouhesh square
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Hamedan University of Medical Sciences; No. 5, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 4058
Email
reza.shokohi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Shaghaghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Pazhouhesh square
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
z.shaghaghi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ramin Mansouri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Rehabilitation management
Street address
Hamadan University of medical sciences; Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6616985667
Phone
+98 939 013 1815
Fax
Email
raminmn4@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Shaghaghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Pazhouhesh square
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
z.shaghaghi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts six months after the results are published
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Our data will be available to all scientific researchers who request via official email.
From where data/document is obtainable
z.shaghaghi@umsha.ac.ur via email
What processes are involved for a request to access data/document
Researchers will receive the data by sending a data access request six months after the article's publication by sending an email to z.shaghaghi@umsha.ac.ur.