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IRCT20211219053450N1 IRCT 2022-06-05 Ahvaz University of Medical Sciences Effect of Empagliflozin on left ventricular volumes in type 2 diabetes or prediabetes patients with heart failure with reduced ejection fraction Effect of Empagliflozin on left ventricular volumes in type 2 diabetes or prediabetes patients with heart failure with reduced ejection fraction 2022-07-16 anticipated 112 Complete https://irct.ir/trial/60756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups of drugs and placebo. In this study, we will use the restricted randomization method of block randomization. The size of all the blocks is the same in both the drug and placebo groups, and we will have 4 blocks in this 2-group experiment. Randomization tool also uses random number tables, Blinding description: Blinding is done in such a way that the person who randomizes and assigns people to groups has no information about the patients' condition and the study process. The patient and the person reviewing the results also did not know what group the people were in, and the study was conducted in a two-way blind. 3 Heart failure. Intervention 1: Intervention group: Impagliflozin drug at a dose of 10 mg is administered once a day for 36 weeks. Intervention 2: Control group: Patients in the control group receive placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Omid Sherafat
Emam Khomeini hospital,Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 8037 omidsherafat70@gmail.com Ahvaz University of Medical Sciences scientific Mohammad Reza Afshani
Emam khomeini hospital,Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 8037 afshani-mr@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with type 2 diabetes mellitus (HbA1C≥ 6.5%) or pre-diabetes (HbA1c between 5.7% to 6.4%) and ischemic heart failure with reduced fractional ejection (LVEF ≤ 40%) over 18 years old Functional NYHA Class II to IV Patient consent for participation in research 18 years no limit Both Type 1 diabetes; Severe liver failure; eGFR <mL / min / 1.73m2 30; History of diabetic ketoacidosis; Existence of any malignancy and cancer; Lack of adherence to the treatment regimen. I50.9 Heart failure, unspecified Treatment - Drugs Placebo Intervention group: Impagliflozin drug at a dose of 10 mg is administered once a day for 36 weeks. Control group: Patients in the control group receive placebo Left ventricular volumes. Timepoint: before and 6 months after intervention. Method of measurement: Echocardiographic parameters. Ahvaz University of Medical Sciences Approved 2021-11-30 Ethics Committee in Research of Golestan Hospital, Ahvaz Golestan street, Golestan hospital,Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)