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IRCT20150617022794N3 IRCT 2024-06-09 Semnan University of Medical Sciences Dapagliflozin and acute heart failure A Study to Test Dapagliflozin in Patients with Acute Heart Failure 2024-07-05 anticipated 200 Recruiting https://irct.ir/trial/77115 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomly assigning people in two groups is permuted block randomization. In this method, A will represent group one (protocol treatment of furosemide with the addition of dapagliflozin 10 mg per day) and B will represent group two (furosemide plus placebo). In this way, the order of interventions A and B in the form of 5 blocks of 8 and 5 blocks of 12 from number 1 to 10 is determined by the methodological consultant of the project and placed at the disposal of the executive supervisor of the project.The executive supervisor selects one of the numbers 0 to 9 (1 to 9 blocks number 1 to 9 and zero is a sign for block number 10) using a table of random numbers, and then the qualified people according to the predetermined (from left to right) are attributed to one of two groups A or B. It should be mentioned in case of crossed consequences, another number (between 0 and 9) will be selected for such person, Blinding description: After signing the consent letter, patients will be entered either in control or intervention group. Included patients are not aware of receiving placebo or the test drug. In addition, physicians and the department staff are blinded from patients allocation. 3 Heart Failure. Intervention 1: Intervention group: 40 mg intravenous furosemide determined by amount of congestion. In addition, patients will receive 10 mg oral Dapagliflozin daily for 5 days (Kimia Pharmaceuticals). In case of patient release, dapagliflozin will be continued (10 mg, daily) for 8 weeks. Patients will be given other drugs according to conventional protocols. Intervention 2: Control group: Intravenous furosemide plus 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 Undecided
public Hooman Bakhshande
Niyayesh Highway
Tehran Iran (Islamic Republic of) 1995614331 22042026 -021 hooman.bakhsande@gmail.com ShaRajaie Cardiovascular, Medical & Research Center scientific Bahador Bagheri
Pharmacy School, Basidj Blvd, Semnan
Semnan Iran (Islamic Republic of) 35147-99442 +98 23 3343 1336 bagherib@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Acute heart failure BNP>100 pg/ml receiving IV furosemide Evidence of congestion 20 years 80 years Both Serum glucose < 80 mg/dL Type 1 diabetes mellitus Systolic blood pressure < 90 mmHg Requirement of inotropic therapy hypersensitivity to SGLT-2 inhibitors Already receiving an SGLT2 inhibitor Pregnancy History of DKA Acute MI I50.0 Systolic (congestive) heart failure Treatment - Drugs Placebo Intervention group: 40 mg intravenous furosemide determined by amount of congestion. In addition, patients will receive 10 mg oral Dapagliflozin daily for 5 days (Kimia Pharmaceuticals). In case of patient release, dapagliflozin will be continued (10 mg, daily) for 8 weeks. Patients will be given other drugs according to conventional protocols. Control group: Intravenous furosemide plus placebo Ejection fraction. Timepoint: At admission and 5 days after receiving the medications and at study termination. Method of measurement: echocardiography. Serum level of Sirtuin-1. Timepoint: At admission and 5 days after receiving the medications. Method of measurement: ELISA. Worsening of clinical conditions. Timepoint: At release till 8 weeks. Method of measurement: Readmission and phone call. Semnan University of Medical Sciences Approved 2024-05-29 Ethics Committee, Semnan University of Medical Sciences School of Medicine, Mashhad Road Semnan Semnan Iran (Islamic Republic of)