Efficacy of Empagliflozin on cardiac function in non- diabetic patients after primary percutaneous angioplasty on left anterior descending coronary artery
Efficacy of empagliflozin on cardiac function in non- diabetic patients after primary PCI on LAD
Design
two arms parallel groups design of 44 patients in each arm randomized trial with blinded recievieg 10 mg empagliflozin daily tablet or placebo
Settings and conduct
trial is designed in Tehran Heart Center. patient and the first researcher are blind to give medication and data gathering. second resercher who monitors data gathering and giving medicine is not blind. in this trial, in first 48 hours of acute MI 10 mg Empagliflozin or placebo give to patient for 3 months. first 48 hours and after three months, ehocardiography is done by an Echocardiologist and blood samples
Participants/Inclusion and exclusion criteria
Enery: non-diabetic patients with PPCI on LAD that are SVD: non-diabetic patients definition: 1-HbA1C<6.5 2-history of non-diabetes 3-twice FBS<100 if two of three of these exist patient is eligible for entery of trial.
exclude: 1-History of serious hypersensitivity to empagliflozin or any component of the formulation; -Severe renal impairment (eGFR <30 mL/minute/1.73 m2), end-stage renal disease (ESRD), or dialysis 2-patients that have more than one vessel disease or have SVD with non-culprit lesion >70% or with SVD of LCX or RCA 3-patients 4- diabetic patients
Intervention groups
two groups and each person recieve one tablet of 10 mg empagliflozin or placebo.
Main outcome variables
Determine decreasing of BNP in arm of reciveing empagliflozin afer three months and comparing
with recieving placebo
determine cardiac systolic and diastolic function after 3 months in two arms and comparing each other
determine decreasing of BNP in arm of reciveing empagliflozin afer 48 thours and comparing with arm of receiving placebo
determine improvement of global longitudinal srain in arm of reciveing empagliflozin afer 48 thours and comparing with arm of receiving placebo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200727048226N1
Registration date:2020-08-06, 1399/05/16
Registration timing:prospective
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Sara Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6582 9828
Email address
hosseinisa1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Empagliflozin on cardiac function in non- diabetic patients after primary percutaneous angioplasty on left anterior descending coronary artery
Public title
Efficacy of Empagliflozin on cardiac function in non- diabetic patients after primary percutaneous angioplasty on left anterior descending coronary artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
non-diabetic patients with PPCI on LAD that are SVD: non-diabetic patients definition: 1-HbA1C<6.5 2-history of non-diabetes 3-twice FBS<100 if two of three of these exist patient is eligible for entery of trial
Exclusion criteria:
1-History of serious hypersensitivity to empagliflozin or any component of the formulation; -Severe renal impairment (eGFR <30 mL/minute/1.73 m2), end-stage renal disease (ESRD), or dialysis 2-patients that have more than one vessel disease or have SVD with non-culprit lesion >70% or with SVD of LCX or RCA 3-patients 4- diabetic patients
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
this trial is a randomized double blind clinical trial with permuted block type of randomization. stratified randomization is done with statistical software.patients enter into blocks including four . and recieving placebo or empagliflozin randomizingly.first physician is blind about type of medication and second physician know the type of medication to find the probable side effect
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and the first researcher are blind to give medication and data gathering. second resercher who monitors data gathering and giving medicine is not blind. in this trial, in first 48 hours of acute MI 10 mg Empagliflozin or placebo give to patient for 3 months. in the first 48 hours , all of the followings are reviewed: 1-demographic data sheet, risk factors, history of cardiovascular diseases. 2- report of angiography is reviewed from PACS. 3- contraindication of recieving of medicine is reviewed. in 48 first 48 hours and after three months, ehocardiography is done by an Echocardiologist and blood samples for FBS, CBC, BUN, Cr, BNP, HbA1C and lipid profile is given.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics of Tehran university of medical science
Street address
north karegar, tehran heart center
City
tehran
Province
Tehran
Postal code
1111111
Approval date
2020-07-30, 1399/05/09
Ethics committee reference number
22222
Health conditions studied
1
Description of health condition studied
acute myocardial infarction
ICD-10 code
121-09
ICD-10 code description
Primary outcomes
1
Description
Efficacy of empagliflozin on cardiac function in non- diabetic patients admitted in Tehran Heart Center after primary PCI on LAD
Timepoint
echocardiography and blood sampling will be done 48 hours and after three months of reciveing medicine
Method of measurement
three dimentional echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: each patient recieves one 10 mg tablet of empagliflozin from abidi institute or placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
tehran heart center
Full name of responsible person
sara hosseini
Street address
north karegar
City
tehran
Province
Tehran
Postal code
111111111
Phone
+98 21 6582 9828
Email
hosseinisa1990@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
institute of researches of tehran university of medical science
Street address
north karegar
City
tehran
Province
Tehran
Postal code
11111111
Phone
+98 21 6582 9828
Email
hosseinisa1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
sara hosseini
Position
cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
north karegar
City
tehran
Province
Tehran
Postal code
111111111
Phone
00921865829828
Email
hosseinisa1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sara hosseini
Position
resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
north karegar
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 6582 9828
Email
hosseinisa1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sara hosseini
Position
resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
north karegar
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 6582 9828
Email
hosseinisa1990@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
some of the information are shared
When the data will become available and for how long
from 6 months afer published
To whom data/document is available
for all researchers and scientists
Under which criteria data/document could be used
analysis in data is allowed
From where data/document is obtainable
hosseinisa@gmail.com
What processes are involved for a request to access data/document
in a week of request in email, recivivig the answer