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IRCT20111206008307N39 IRCT 2022-10-27 Tabriz University of Medical Sciences Effects of Colchicine and Empagliflozin in Myocardial Dysfunction Evaluation Effects of Colchicine and Empagliflozin in with Reduced Ejection Fraction following MI: A Randomized Double-blind Placebo-controlled Trial 2023-02-09 anticipated 96 Complete https://irct.ir/trial/66216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Condition 1: Heart failure. Condition 2: ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction. Intervention 1: Intervention group 1: Patients will receive 25 mg of empagliflozin daily for three months with standard treatments. Intervention 2: Intervention group 2: Patients will receive 1 mg of colchicine and 10 mg of empagliflozin daily for three months with standard treatments. Intervention 3: Control group: Control group: Patients will receive 10 mg empagliflozin daily for three months with standard treatments. 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 scientific institutions. 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 Taher Entezari-Maleki
Shahid Madani Center, Daneshghah Street,Tabriz
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 5983 tentezari@gmail.com Tabriz University of Medical Sciences scientific Taher Entezari-Maleki
Faculty of Pharmacy, Daneshghah Street,Tabriz
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 5983 tentezari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Heart Failure with Reduced Ejection Fraction Aged 18 to 80 years Consented patients 18 years 80 years Both 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 I50 I21 Heart failure ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients will receive 25 mg of empagliflozin daily for three months with standard treatments Intervention group 2: Patients will receive 1 mg of colchicine and 10 mg of empagliflozin daily for three months with standard treatments. Control group: Control group: Patients will receive 10 mg empagliflozin daily for three months with standard treatments. High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test. New York Heart Association (NYHA) Functional Classification. Timepoint: At baseline and 1, and 3 months after intervention. Method of measurement: Assessment by one cardiologist. Left ventricular diastolic function. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography. Left ventricular end-diastolic diameter. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography. Mitral valve regurgitation grade. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography. Tumour Necrosis Factor alpha (TNF alpha). Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test. Ejection fraction. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography. Total antioxidant capacity. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test. Malondialdehyde. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test. ٍEmpagliflozin serum concentration. Timepoint: One and three months after intervention. Method of measurement: Laboratory test. Left ventricular diastolic function. Timepoint: One and three months after intervention. Method of measurement: Echocardiography. Tabriz University of Medical Sciences Approved 2022-07-30 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)