Evaluation of quality of life in patients with heart failure treated with colchicine
Design
Clinical trial with control group, with parallel groups, uncorrected, randomized, phase 2_3 on 60 patients
Settings and conduct
This is a prospective ‚ randomized controlled trial on a total 60 consented of patients with heart failure in the age group over 18 years and under 80 years who have filled out the informed consent form. And to treat their heart failure ‚ they have referred to the clinic of Shahid Madani Research and Treatment Center in Tabriz .In addition to routine treatment ‚patients in the intervention group will also receive 0.5 mg twice daily colchicine. Examination of inflammatory femurs will be three times (before starting treatment with colchicine and one month later and three months later).
Participants/Inclusion and exclusion criteria
The condition for entering this research project include these items ;Patients with heart failure which completed the consent form.
The condition for not entering this research project are as follow ; Patients with heart failure with colchicine allergy and patients with heart failure who have not completed the consent form.
Intervention groups
Intervention group will receive in addition to routine treatment‚0.5 mg twice a day of colchicine. Patient in the control group will receive only routine treatment.
Main outcome variables
Evaluation of changes in serum levels of inflammatory factors in heart failure and change in quality of life in patients with heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N38
Registration date:2022-04-09, 1401/01/20
Registration timing:registered_while_recruiting
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
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
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of quality of life in patients with heart failure treated with colchicine
Public title
Evaluation of quality of life in patients with heart disease being treated with colchicine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart failure
Patients with a history of cardiac ischemia
Patients with a history of thromboembolism
Patients with high serum levels of inflammatory factors in heart failure and cardiovascular problems
Patients with less renal glomerular filtration rate 30mm Hg /min/1.73 m2
Patients with symptomatic hypotension and systolic pressure below 100 or above 180 mm Hg
Complete the consent form
Exclusion criteria:
Patients with heart failure who are treated on an outpatient basis and do not need to be hospitalized
Patients with heart failure are in the age group under 18 years and over 80 years
Patients with heart failure with colchicine allergy
Patients with heart failure who have not completed the consent form
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Patients will be sampled by more than one sample per patient and the sample size will be pilot.
Randomization (investigator's opinion)
Randomized
Randomization description
Given that the number of cases in this research project is 60 people which should be randomly divided into two groups of 30 people ‚so; How to randomize in this research project will be done as follow which patients will be divided into two groups of 30 by systematic randomization and computer generated numbers .
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
Ethic committee of Tabriz University of Medical Scienc
Street address
Research and Technology Deputy‚ Tabriz University of Medical Science‚Golgasht Street‚ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.TBZMED.REC.1400.1132
Health conditions studied
1
Description of health condition studied
Patients with heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Changes in the quality of life of heart failure patients with administration of the drug
Timepoint
Evaluation and determination of quality of life in patients with heart failure at the beginning of the study (before the intervention), 30 days and 90 days after the intervention
Method of measurement
Using the completion of the KCCQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes patients with heart failure who in addition to standard treatment will also take 0.5 mg twice a day colchicine tablet for three months.
Category
Treatment - Drugs
2
Description
Control group: The control group includes patients with heart failure who will receive only the standard treatment of heart failure.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabri
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
Dr.Mohammad Reza Rashidi
Street address
Daneshghah Street‚ Golgasht Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
335710
Phone
+98 41 3335 7310
Email
tentezari@gmail.com
Web page address
http://researchvice.tbzmed.ac.ir
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
Dr. Taher Entezari-Maleki
Position
Assistant professor/ Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
0098 41 33344798
Phone
+98 41 1339 2593
Fax
+98 41 1334 4798
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Taher Entezari-Maleki
Position
Assistant professor/Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy ‚ Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
0098 41 33344798
Phone
+98 41 1339 2593
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
Assistant professor/ Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1339 2593
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 scintific institution
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 .