The effect of Empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI
Evaluation of the effect of empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary percutaneous coronary intervention(PCI)
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 64 patients Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward of Ghaem Hospital in Mashhad. Patients are randomly assigned to Empagliflozin and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-diabetic patients,Patients with ejection fraction≤40, Patients with Anterior ST elevation Myocardial infarction,Patients undergoing primary Percutaneous coronary intervention(PCI), The possibility of follow up patients for echocardiography, Consent to admission to the study
Exclusion criteria: Patients who are candidates for medical therapy after angiography,Patients who are candidates for CABG after angiography, Patients with a history of clinical heart failure,patients with a history of anterior STEMI,Patients with a history of PCI on LAD
Intervention groups
Intervention group: Non-diabetic Patients with acute anterior ST-elevation myocardial infarction treated with primary Percutaneous coronary intervention(PCI) receiving Empagliflozin 10 mg once daily for 40 days along with common treatments. Placebo group: Non-diabetic patients with acute anterior ST-elevation MI treated with primary PCI receiving a placebo tablets once daily for 40 days along with common treatments
Main outcome variables
Ejection fraction of left ventricle at the beginning of the study and after 40 days of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221227056950N1
Registration date:2023-01-14, 1401/10/24
Registration timing:registered_while_recruiting
Last update:2023-01-14, 1401/10/24
Update count:0
Registration date
2023-01-14, 1401/10/24
Registrant information
Name
Bahar Moshfegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 4519
Email address
moshfeghb70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-12, 1401/10/22
Expected recruitment end date
2025-01-11, 1403/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI
Public title
The effect of Empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-Diabetic patients
Patients with ejection fraction≤40
Patients with anterior ST elevation myocardial infarction
Patients undergoing primary percutaneous coronary intervention(PCI)
The possibility of patient follow up for electrocardiography
Consent to admission to the study
Exclusion criteria:
Patients who are candidates for medical therapy after angiography
Patients who are candidates for CABG after angiography
patients with a history of clinical heart failure
patients with a history of Anterior STEMI
Patients with a history of PCI on LAD
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 16 blocks according to the sample size of 64. Then random numbers between 1 and 16 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Mashhad University of Medical Sciences
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.522
Health conditions studied
1
Description of health condition studied
Acute anterior ST elevation Myocardial infarction treated with primary PCI
ICD-10 code
I21.0
ICD-10 code description
ST elevation (STEMI) myocardial infarction of anterior wall
Primary outcomes
1
Description
Ejection fraction of left ventricle
Timepoint
Ejection fraction of left ventricle at the beginning of the study and after 40 days of treatment.
Method of measurement
Echocardioghraphy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving Empagliflozin10 mg once daily for 40 days
Category
Treatment - Drugs
2
Description
Control group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving a placebo tablets once daily for 40 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
leila bigdelu
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3801 2739
Email
www.moshfeghb70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
www.moshfeghb70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bahar moshfegh
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 1.54, Mohtashami 18
City
Mahhad
Province
Razavi Khorasan
Postal code
9176686795
Phone
+98 51 3844 4519
Email
www.moshfeghb70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahar moshfegh
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No.1.54,Mohtashami18
City
Mashhad
Province
Razavi Khorasan
Postal code
9176686795
Phone
+98 51 3844 4519
Email
www.moshfeghb70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahar moshfegh
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No.1.54,Mohtashami 18
City
Mashhad
Province
Razavi Khorasan
Postal code
9176686795
Phone
+98 51 3844 4519
Email
www.moshfeghb70@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