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Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial

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History
# Registration date Revision Id
4 2023-05-23, 1402/03/02 266493
3 2023-01-22, 1401/11/02 253380
2 2023-01-05, 1401/10/15 251651
1 2022-10-27, 1401/08/05 243924
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  • Primary outcomes

    #1
    Before intervention and 1, and 3 months after intervention
    At baseline and 1, and 3 months after intervention
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    در حالت پايه و 1 و 3 ماه بعد از شروع مداخله
    #2
    Tumour Necrosis Factor alpha (TNF alpha)
    empty
    فاکتور نکروز توموری آلفا
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Laboratory test
    empty
    تست آزمایشگاهی
    empty
    #3
    Ejection fraction
    empty
    کسر تخلیه
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    empty

  • Secondary outcomes

    #1
    empty
    Left ventricular diastolic function
    empty
    اختلال عملکرد دیاستولیک
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    #2
    empty
    Left ventricular end-diastolic diameter
    empty
    دیامتر پایان سیستولیک بطن چپ
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    #3
    empty
    Mitral valve regurgitation grade
    empty
    شدت نارسایی دریچه میترال
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    #4
    empty
    Tumour Necrosis Factor alpha (TNF alpha)
    empty
    فاکتور نکروز توموری آلفا
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Laboratory test
    empty
    تست آزمایشگاهی
    #5
    empty
    Ejection fraction
    empty
    کسر تخلیه
    empty
    Before intervention and 1, and 3 months after intervention
    empty
    قبل از شروع مداخله و 1 و 3 ماه بعد از شروع مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی

Protocol summary

Study aim
Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction
Design
Clinical trial with control group, with parallel group design, 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
This is a randomized clinical trial on a total of 96 patients over 18 years with heart failure with reduced ejection fraction who attended the Shahid Madani clinic of Tabriz University of Medical Science. Patients in 2 intervention and one control groups will receive empagliflozin and colchicine. Patients will be compared regarding serum level of hs-CRP, NYHA Functional Classification, serum level of TNF alpha, and ejection fraction in three groups using SPSS by appropriate statistical tests (before starting treatment and one month later and three months later). .
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. Pregnancy 2. Lactation 3. Liver failure 4. Kidney failure 5. Contraindications of colchicine or empagliflozin 6. Systolic blood pressure less than 100 or more than 180 mm Hg 7. Symptomatic hypotension 8. Autoinflammatory diseases 9. Malignancy 10. Diabetes mellitus
Intervention groups
In intervention group 1, patients will receive 25 mg of empagliflozin daily for three months with standard treatments. In intervention group 2, patients will receive 1 mg of colchicine and 10 mg of empagliflozin daily for three months with standard treatments. In control group, Patients will receive 10 mg empagliflozin daily for three months with standard treatments.
Main outcome variables
1. hs-CRP 2. NYHA Functional Classification 3.TNF alpha 4. Ejection fraction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111206008307N39
Registration date: 2022-10-27, 1401/08/05
Registration timing: prospective

Last update: 2023-01-07, 1401/10/17
Update count: 3
Registration date
2022-10-27, 1401/08/05
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
2022-11-01, 1401/08/10
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial
Public title
Effects of Colchicine and Empagliflozin in 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 Contraindications of colchicine or empagliflozin Systolic blood pressure less than 100 or more than 180 mm Hg Symptomatic hypotension Autoinflammatory diseases Malignancy Diabetes mellitus
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: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
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
2022-07-30, 1401/05/08
Ethics committee reference number
IR.TBZMED.REC.1401.370

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
High-sensitivity C-reactive protein (hs-CRP)
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Laboratory test

2

Description
New York Heart Association (NYHA) Functional Classification
Timepoint
At baseline and 1, and 3 months after intervention
Method of measurement
Assessment by one cardiologist

Secondary outcomes

1

Description
Left ventricular diastolic function
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Echocardiography

2

Description
Left ventricular end-diastolic diameter
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Echocardiography

3

Description
Mitral valve regurgitation grade
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Echocardiography

4

Description
Tumour Necrosis Factor alpha (TNF alpha)
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Laboratory test

5

Description
Ejection fraction
Timepoint
Before intervention and 1, and 3 months after intervention
Method of measurement
Echocardiography

Intervention groups

1

Description
Intervention group 1: Patients will receive 25 mg of empagliflozin daily for three months with standard treatments
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients will receive 1 mg of colchicine and 10 mg of empagliflozin daily for three months with standard treatments.
Category
Treatment - Drugs

3

Description
Control group: 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
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,Tabriz
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
Faculty of Pharmacy, 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
Taher Entezari-Maleki
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.
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