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General information
Not blinded
Double blinded
notbldoubl
1
1
1
1
Not used
Used
nusedused
2022-11-01, 1401/08/10
2023-02-09, 1401/11/20
20222023-1102-0109 00:00:00
2023-03-11, 1401/12/20
2023-06-10, 1402/03/20
2023-0306-1110 00:00:00
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Considering that the study will start on 2 February 9, 2023, the approximate start time of the study was changed. Considering that the classification of the New York Heart Association, which is a subjective finding, will be used to evaluate patients' heart failure, the blinding process of participants and health-care providers have been explained.
Considering that the study will start on 2 February 9, 2023, the approximate start time of the study was changed. Considering that the classification of the New York Heart Association, which is a subjective finding, will be used to evaluate patients' heart failure, the blinding process of participants and health-care providers have been explained.
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با توجه با اینکه مطالعه در تاریخ 20 بهمن 1401 شروع خواهد شد زمان تقریبی شروع مطالعه تغییر داده شد. با توجه به اینکه از طبقه بندی انجمن قلب نیویورک که یک یافته ذهنی می باشد جهت ارزیابی نارسایی قلب بیماران استفاده خواهد شد نحوه کورسازی شرکت کنندگان و کادر درمان توضیح داده شد.
با توجه با اینکه مطالعه در تاریخ 20 بهمن 1401 شروع خواهد شد زمان تقریبی شروع مطالعه تغییر داده شد. با توجه به اینکه از طبقه بندی انجمن قلب نیویورک که یک یافته ذهنی می باشد جهت ارزیابی نارسایی قلب بیماران استفاده خواهد شد نحوه کورسازی شرکت کنندگان و کادر درمان توضیح داده شد.
Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial
Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized Double-blind Placebo-controlled Trial
Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized ClinicalDouble-blind Placebo-controlled Trial
بررسی اثرات کلشیسین و امپاگلیفولازین در نارسایی قلب با کسر تخلیه کاهش یافته: یک کارآزمایی بالینی تصادفی
بررسی اثرات کلشیسین و امپاگلیفولازین در نارسایی قلب با کسر تخلیه کاهش یافته: یک کارآزمایی بالینی دوسوکور تصادفی شده با کنترل دارونما
بررسی اثرات کلشیسین و امپاگلیفولازین در نارسایی قلب با کسر تخلیه کاهش یافته: یک کارآزمایی بالینی دوسوکور تصادفی شده با کنترل دارونما
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)
Randomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 6 and 9.
Arrangement of theRandomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization process: 1) Determining the volume of eachmethod with random block (quadruple blocks) 2) Preparing the list of the blockssize 6 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)9.
ترتیب مراحل تصادف سازی: 1) مشخص نمودن حجم هر بلوک (بلوک های 4 تایی) 2) تهیه لیست بلوک ها و اختصاص عدد به آن ها (6)AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB 3) انتخاب اعداد تصادفی بین 1 الی 6 4) مشخص نمودن لیست تخصیص درمان (Treatment Assignment) برای مثال: (5)AABB(1)_BBAA(4)_ABAB(2)_BABA
تصادفی سازی با استفاده از سایت تخصیص تصادفی (https://www.sealedenvelope.com/simple-randomiser/v1/lists) به روش تصادفی بلوکی با اندازه بلوک های تصادفی 6 و 9 انجام خواهد شد.
ترتیب مراحل تصادفتصادفی سازی با استفاده از سایت تخصیص تصادفی (https: 1//www.sealedenvelope.com/simple-randomiser/v1/lists) مشخص نمودن حجم هر بلوک (به روش تصادفی بلوکی با اندازه بلوک های 4 تایی) 2) تهیه لیست بلوک هاتصادفی 6 و اختصاص عدد به آن ها (6)AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB 3) انتخاب اعداد تصادفی بین 1 الی 6 4) مشخص نمودن لیست تخصیص درمان (Treatment Assignment) برای مثال: (5)AABB(1)_BBAA(4)_ABAB(2)_BABA9 انجام خواهد شد.
Participants and health care providers are not aware of the type of grouping of patients, and the study drug will be unrecognizable to patients and related treatment staff. A matched placebo is identical to colchicine in every aspect, such as appearance, smell, and taste. The only person who will know the type of drug is the coordinator of the study.
Participants and health care providers are not aware of the type of grouping of patients, and the study drug will be unrecognizable to patients and related treatment staff. A matched placebo is identical to colchicine in every aspect, such as appearance, smell, and taste. The only person who will know the type of drug is the coordinator of the study.
افراد شرکت کننده و پرسنل بهداشتی درمانی از نوع گروه بندی بیماران آگاهی ندارند، و داروی مورد مطالعه برای بیماران و کادر درمانی مربوطه غیر قابل تشخیص خواهد بود. دارونمای منطبق از هر جنبه مانند ظاهر، بو و مزه با کلشی سین یکسان است. تنها کسی که از نوع دارو مطلع خواهد بود هماهمگ کننده مطالعه حواهد بود.
افراد شرکت کننده و پرسنل بهداشتی درمانی از نوع گروه بندی بیماران آگاهی ندارند، و داروی مورد مطالعه برای بیماران و کادر درمانی مربوطه غیر قابل تشخیص خواهد بود. دارونمای منطبق از هر جنبه مانند ظاهر، بو و مزه با کلشی سین یکسان است. تنها کسی که از نوع دارو مطلع خواهد بود هماهمگ کننده مطالعه حواهد بود.
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.
Considering that the study will start on 2 February 9, 2023, the approximate start time of the study was changed. Considering that the classification of the New York Heart Association, which is a subjective finding, will be used to evaluate patients' heart failure, the blinding process of participants and health-care providers have been explained.
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N39
Registration date:2022-10-27, 1401/08/05
Registration timing:prospective
Last update:2023-01-23, 1401/11/03
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
2023-02-09, 1401/11/20
Expected recruitment end date
2023-06-10, 1402/03/20
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 Double-blind Placebo-controlled 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
Participant
Care provider
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 6 and 9.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and health care providers are not aware of the type of grouping of patients, and the study drug will be unrecognizable to patients and related treatment staff. A matched placebo is identical to colchicine in every aspect, such as appearance, smell, and taste. The only person who will know the type of drug is the coordinator of the study.
Placebo
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.