Evaluation effect of empaglifulazin on depression in patients with heart failure with reduced ejection fraction
Design
A controlled, parallel-group, blinded, phase 3 clinical trial of 50 patients.
Settings and conduct
This study is conducted as a randomized clinical trial on 50 patients over 18 years of age with heart failure with reduced ejection fraction who have referred to Shahid Madani Research and Treatment Center in Tabriz. The patients in the intervention groups will receive empagliflozin 25 mg and routine treatment. The patients In control group will receive empagliflozin 10 mg and routine treatment. Patients' depression will be evaluated and compared using the Hamilton grading scaleand at baseline and in months 1 and 3.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Heart failure with reduced ejection fraction 2. Aged 18 to 80 years 3. Consented patients
Exclusion criteria: 1. History of using empagliflozin 2. Kidney failure 3. Symptomatic hypotension 4. Systolic pressure below 100 or above 180 mm Hg 5. Contraindications of empagliflozin 6. Liver failure 7. Pregnancy 8. Lactation 9. Malignancy
Intervention groups
Patients in intervention group will receive 25 mg empagliflozin daily in addition to the usual treatments. Patients in control group will receive 10 mg of empagliflozin daily for three months in addition to the usual treatments.
Main outcome variables
Hamilton grading scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N41
Registration date:2022-11-17, 1401/08/26
Registration timing:prospective
Last update:2022-11-17, 1401/08/26
Update count:0
Registration date
2022-11-17, 1401/08/26
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of empaglifulazin on depression in patients with heart failure with reduced ejection fraction: a randomizd clincal trial
Public title
Evaluation effect of empaglifulazin on depression in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Heart failure with reduced ejection fraction
Aged 18 to 80 years
Consented patients
Exclusion criteria:
History of using empagliflozin
Kidney failure
Symptomatic hypotension
Systolic pressure below 100 or above 180 mm Hg
Contraindications of empagliflozin
Liver failure
Pregnancy
Lactation
Malignancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using computer generated random number (systematic randomization) by online Graphpad software by determining 2 study groups and 25 patients in each group (Control and Intervention) by an independent person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reach etich committee of tabriz university of medical sciences
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2022-08-22, 1401/05/31
Ethics committee reference number
IR.TBZMED.REC.1401.461
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Hamilton score chek list
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Hamilton depression checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 25 mg of empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months in addition to the standard treatments for the treatment of heart failure with reduced ejection fraction.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive 10 mg empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months with standard treatments for the treatment of heart failure with reduced ejection fraction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center
Full name of responsible person
Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3901
Fax
Email
tentezari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht, Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associated professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Center, Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-maleki
Position
Associated professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Heart Center, Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Fax
+98 41 1334 4798
Email
tentezari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associated professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Heart Center, Daneshghah stree
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Fax
Email
tentezari@gmail.com
Web page address
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of an article can be published after making patients unrecognized.
When the data will become available and for how long
After publishing of article until 6 months after publishing of the result
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims.
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.
What processes are involved for a request to access data/document
After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be send to applicants.