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IRCT20111206008307N38 IRCT 2022-04-09 Tabriz University of Medical Sciences Evaluation of quality of life in patients with heart disease being treated with colchicine Evaluation of quality of life in patients with heart failure treated with colchicine 2022-02-20 anticipated 60 Complete https://irct.ir/trial/61933 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 . 2-3 Patients with heart failure. Intervention 1: 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. Intervention 2: Control group: The control group includes patients with heart failure who will receive only the standard treatment of heart failure. Yes - There is a plan to make this available What will be shared: All of the data of an article can be published after making patients unrecognized When: After publishing of article until 6 months after publishing of the results To whom: Data will be available to researchers working in academic and scintific institution Conditions: Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims Where to obtain: Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr.Taher Entezari-Maleki How to obtain: 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 . Comments:
public Dr. Taher Entezari-Maleki
Daneshghah street
Tabriz Iran (Islamic Republic of) 0098 41 33344798 +98 41 1339 2593 tentezari@gmail.com Tabriz University of Medical Sciences scientific Dr.Taher Entezari-Maleki
Faculty of pharmacy ‚ Daneshghah Street
Tabriz Iran (Islamic Republic of) 0098 41 33344798 +98 41 1339 2593 tentezari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 I50 Heart failure Treatment - Drugs Treatment - Other 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. Control group: The control group includes patients with heart failure who will receive only the standard treatment of heart failure. 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. Tabriz University of Medical Sciences Approved 2022-02-09 Ethic committee of Tabriz University of Medical Scienc Research and Technology Deputy‚ Tabriz University of Medical Science‚Golgasht Street‚ Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)