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IRCT20111206008307N45 IRCT 2024-02-27 Tabriz University of Medical Sciences Effects of Dapagliflozin and Empagliflozin in Myocardial Dysfunction Evaluation Effects of Dapagliflozin and Empagliflozin in Nondiabetic Patients with Left Ventricular Systolic Dysfunction following ST Elevation Myocardial Infarction : A Randomized Clinical Trial 2024-02-20 anticipated 75 Complete https://irct.ir/trial/75282 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: Determining each block size (quadruple blocks), 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), Choosing random numbers between 1 and 6 by Excel software, Defining the treatment assignment list. For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: This study is double-blind and none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups. For this purpose, dapagliflozin, empagliflozin and placebo will be similarly packaged and given to the patient. Also, dapagliflozin, empagliflozin and placebo tablets will have the same shape, color, and size. 3 Condition 1: Heart failure. Condition 2: Myocardial infarction. Intervention 1: Intervention group: Patients will receive 10 mg empagliflozin daily for 40 days in addition to usual treatments. Intervention 2: Intervention group: Patients will receive 10 mg dapagliflozin daily for 40 days in addition to usual treatments. Intervention 3: Control group: Patients will receive a placebo daily for 40 days along with usual 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 who request data will be permitted only to do 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 the corresponding author(Dr. Taher Entezari Maleki), data will be sent to the Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be sent 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 Renal failure (estimated glomerular filtration rate less than 30 ml/min) Patients with a history of taking dapagliflozin or empagliflozin Diabetes mellitus Contraindications of dapagliflozin or empagliflozin Inflammatory and autoimmune diseases Systolic blood pressure less than 100 or more than 180 mm Hg Symptomatic hypotension Malignancy I50 I21 Heart failure ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients will receive 10 mg empagliflozin daily for 40 days in addition to usual treatments. Intervention group: Patients will receive 10 mg dapagliflozin daily for 40 days in addition to usual treatments. Control group: Patients will receive a placebo daily for 40 days along with usual treatments. New York Heart Association (NYHA) Functional Classification. Timepoint: At baseline and 40 days after intervention. Method of measurement: Assessment by one cardiologist. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At baseline and 40 days after intervention. Method of measurement: Laboratory test. NT-proBNP. Timepoint: At baseline and 40 days after intervention. Method of measurement: Laboratory test. Ejection fraction. Timepoint: At baseline and 40 days after intervention. Method of measurement: Echocardiography. Left ventricular end‐diastolic volume. Timepoint: At baseline and 40 days after intervention. Method of measurement: Echocardiography. Hospitalization due to cardiovascular reasons. Timepoint: Within 40 days after intervention. Method of measurement: Interview. Tabriz University of Medical Sciences Approved 2023-09-11 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)