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IRCT20111206008307N41 IRCT 2022-11-17 Tabriz University of Medical Sciences Evaluation effect of empaglifulazin on depression in patients with heart failure Evaluation effect of empaglifulazin on depression in patients with heart failure with reduced ejection fraction: a randomizd clincal trial 2022-11-22 anticipated 50 Complete https://irct.ir/trial/66562 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using computer generated random number (systematic randomization) by online Graphpad software by determining 2 study groups and 25 patients in each group (Control and Intervention) by an independent person. 3 Heart failure. Intervention 1: Intervention group: Patients will receive 25 mg of empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months in addition to the standard treatments for the treatment of heart failure with reduced ejection fraction. Intervention 2: Control group: Patients will receive 10 mg empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months with standard treatments for the treatment of heart failure with reduced ejection fraction. 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 result 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 Iran (Islamic Republic of) 5166414766 +98 41 3335 5983 tentezari@gmail.com Tabriz University of Medical Sciences scientific Taher Entezari-maleki
Shahid Madani Heart Center, Daneshghah street
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 History of using empagliflozin Kidney failure Symptomatic hypotension Systolic pressure below 100 or above 180 mm Hg Contraindications of empagliflozin Liver failure Pregnancy Lactation Malignancy I50.2 Systolic (congestive) heart failure Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 25 mg of empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months in addition to the standard treatments for the treatment of heart failure with reduced ejection fraction. Control group: Patients will receive 10 mg empagliflozin (Gloripa, Abidi Pharmaceutical Company) daily for three months with standard treatments for the treatment of heart failure with reduced ejection fraction. Hamilton score chek list. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Hamilton depression checklist. Tabriz University of Medical Sciences Approved 2022-08-22 Reach etich committee of tabriz university of medical sciences Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)