The effectiveness of Empagliflozin on clinical and echocardiographic findings of patients with heart failure, in order to improve outcome
Design
A double blinded randomized controlled trial was conducted. This study was designed based on the principles of Helsinki and " GOOD CLINICAL PRACTICE" principles. The study was single - center; the subjects were randomly divided into two groups ( i.e. 44 random number in excel to divide the coded people into intervention and control groups ). The change in the LVEF was assesed; the sample size in each group is 22 and in total 44 people.
Settings and conduct
The drug and placebo were put in similar cans by a neutral person ( other than the research members ), called a and b. Participants will not be aware of either drug or placebo. The patients were randomly divided into two groups and control group. The study will be conducted on individuals of the heart clinic of Imam Hussain Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 80 years old; heart failure with EF less and equal 40 %; no history for diabetes.
Exclusion criteria: pregnancy or lactation; any history of diabetes, hospitalization due to cardiovascular event or renal disease over the last three months; GFR less than 45 mL / min / m2; systolic blood pressure less than 90 mmHg.
Intervention groups
Intervention group: Empagliflozin 10 mg will administer orally, daily for eight weeks. Control group: placebo is a medication that contains vitamin B1,100 mg, daily, for eight weeks .
Main outcome variables
The change of echocardiographic indicators and clinical indicators included quality of life, physical activity and clinical signs of heart failure after 8 weeks from the start of consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210809052117N1
Registration date:2022-06-25, 1401/04/04
Registration timing:prospective
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Nasim Arabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7746 0902
Email address
nasimarabbreeze@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-28, 1401/04/07
Expected recruitment end date
2022-07-18, 1401/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Empagliflozin on clinical and echocardiographic parameters in non diabetic patient with reduced LVEF heart failure
Public title
Effect of Empagliflozin on clinical and echocardiographic parameters in patient with reduced LVEF heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 yr_80 yr
Heart failure with reduced EF <40%
Nondiabetic
Stable symptom and therapy for heart failure
Exclusion criteria:
Cardiovascular event, admission for cardiovascular or renal complications within last 3 months
Cancer or life-threatening condition
Estimated GFR < 45 ml/min/m2
Systolic blood pressure < 90mmhg
Pregnancy or lactating women
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by table number method, Odd numbers to case group and even numbers to control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study: placebo and empagliflozin were placed in two cans of same form and a color that named A , B. Participants and resercher, who include clinical care and outcome evaluator, did not know the nature of the contents of cans A , B .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofShahid Beheshti University of Medical Sciences
The beginning of the study and 8 weeks after start of empagliflozin
Method of measurement
Echocardiography
2
Description
Quality of life
Timepoint
The beginning of the study and 8 weeks after start of empagliflozin
Method of measurement
Kansas questionnaire
3
Description
Physical activity
Timepoint
The beginning of the study and 8 weeks after start of empagliflozin
Method of measurement
NYHA Class and 6-MWT
Secondary outcomes
1
Description
Renal function
Timepoint
The beginning of the study and 8 weeks after start of empagliflozin
Method of measurement
Creatinine measuring and computing Glomerular Filtration Rate
2
Description
Cardiac mortality
Timepoint
During the study
Method of measurement
Follow up
3
Description
Myocardial Infurction
Timepoint
During the study
Method of measurement
Follow up
4
Description
Duration of hospitalization for cardiac causes
Timepoint
During the study
Method of measurement
Follow up
Intervention groups
1
Description
Intervention group: patient known case of heart failure, nondiabetic,18_80yr with EF 40% or less and on standard HF treatment that confer to EMAM HOSSEIN cardiovascular Clinic; they receive empagliflozin 10 mg, daily
Category
Treatment - Drugs
2
Description
Control group: patient known case of heart failure, nondiabetic,18_80yr with EF 40% or less and on standard HF treatment that confer to EMAM HOSSEIN cardiovascular Clinic, they receive vit B1 100 mg, daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein hospital,Cardiovascular Clinic
Full name of responsible person
Nasim Arabzade
Street address
Madani Ave
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir
Web page address
https://ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Velenjak, Chamran Blvd., Yaman Ave., Arabi Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Arabzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Velenjak, Chamran Blvd., Yaman Ave., Arabi Street
City
تهران
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nasimarabbreeze@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Arabzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Velenjak, Chamran Blvd., Yaman Ave., Arabi Street
City
تهران
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nasimarabbreeze@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Arabzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Velenjak, Chamran Blvd., Yaman Ave., Arabi Street
City
تهران
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nasimarabbreeze@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data file of the participants , the study protocol , the statistical analysis map ,consciously Consent form , the clinical study report , codes used in analysis , data classification system ( data dictionary )
When the data will become available and for how long
Start the access period , 6 months after the results were published .
To whom data/document is available
It will only be available for researchers working in academic and academic institutions , or those involved in the industry can act to receive them .
Under which criteria data/document could be used
in order to conduct more research studies , such as multicenter of study and more complex analyses will be provided to other researchers .