Evaluation Effects of Coadministration of Empagliflozin and Colchicine on Quality of life in Heart Failure with Reduced Ejection Fraction with Using the KCCQ quality of life rating scale at baseline and in months 1and 3.
Design
Clinical trial with control group,not blind, randomized, phase 3, with a sample size of 96 patients. Randomization was performed using block randomization method by an independent person.
Settings and conduct
48 patients are randomly divided into two groups. Patients in the first group are treated with colchicine and empagliflozin , and the second group are treated with empagliflozin for 6 months. All patients will receive their standard treatment. After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Colchicine and empagliflozin tablets and their placebo are identical in shape, color and size and are delivered to the patient in the package
Participants/Inclusion and exclusion criteria
Patients with a history of taking colchicine or empagliflozin, eGFR <30 mL/min/1.73 m2, inflammatory and autoimmune diseases, symptomatic hypotension, systolic pressure below 100 or above 180 mm Hg, and other drug contraindications are excluded from the study. .
Intervention groups
In addition to the standard treatment, patients in the intervention group will also receive empagliflozin at a dose of 10 mg daily and colchicine at a dose of 1 mg daily for 3 months.
Evaluation Effect of Empagliflozin and Colchicine on Quality of life in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial
Public title
Effects of Coadministration of Empagliflozin and Colchicine on Heart Failure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Heart Failure with Reduced Ejection Fraction
Aged 18 to 80 years
Consented patients
Exclusion criteria:
Pregnancy
Lactation
Liver failure
Kidney failure
Systolic blood pressure less than 100 or more than 180 mm Hg
Diabetes mellitus
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
The patients are randomly divided into 2 groups of 25 people by the numbers obtained from the computer, and none of the people will be informed about the randomization samples and the interpretation process.
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
Ethics Committee of Tabriz University of Medical Sciences.
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TBZMED.REC.1401.096
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
Quality of life score in KCCQ questionnaire.
Timepoint
The beginning of the study and months 3 and 6
Method of measurement
KCCQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 25 mg of empagliflozin daily for three months with standard treatments
Category
Treatment - Drugs
2
Description
Control group: Patients will receive 10 mg empagliflozin daily for three months with standard treatments
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabriz
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3901
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
Tabriz, Daneshghah Street‚ Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
335710
Phone
+98 41 3334 4280
Email
tentezari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Tabriz University of Medical Sciences
Position
Taher Entezari-Maleki
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Center, Daneshghah Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 912 635 0900
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tabriz University of Medical Sciences
Position
Associated professor of Clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Center, Daneshghah Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tabriz University of Medical Sciences
Position
Associated professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Daneshghah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@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
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 results
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.