]>
IRCT20240707062351N1 IRCT 2024-10-17 Shahid Beheshti University of Medical Sciences the effect of empagliflozin on heart function in patients with chronic obstructive pulmonary disease the effects of SGLT2 inhibitor drugs in reducing acute COPD attacks and right ventricular function and parameters in non-diabetic patients with chronic obstructive pulmonary disease (COPD) with right ventricular dysfunction and normal left ventricular functio 2024-09-22 anticipated 86 Complete https://irct.ir/trial/79487 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: All eligible people will be randomly assigned to one of the two drug receiving groups with a ratio of 1:1. Randomization method as permuted block randomization will be based on the sample size in 13 blocks of sizes 2, 4, 6, 8, and 10 using the package "Ralloc" will be done in STATA.14 software. Patients were determined based on the sample size and randomized based on the list of people (along with the research code). specific about each person (will be entered in each group), Blinding description: This study is single blind. The person in charge of data analysis will not be aware of the division of empagliflozin and control group. 3 chronic obstructive pulmonary disease. Intervention 1: Intervention group:Daily use of empagliflozin 10 mg orally manufactured by an Iranian pharmaceutical company for a maximum of 3 months after discharge. Intervention 2: Control group: It will include patients who meet the inclusion criteria but do not receive any intervention and are only under standard medical care according toThe clinical trial protocol will be monitored and followed up for a maximum of three months after discharge from the hospital. 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 It has not been decided yet
public Saman Keshvari Asl
South Hassan bana Ave
Tehran Iran (Islamic Republic of) 1633917516 +98 21 7343 2335 dr_samank@yahoo.com Shahid Beheshti University of Medical Sciences scientific Amirbehnam Kharazmi
Madani
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 drkharazmy@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age more than 40 years Having chronic obstructive pulmonary disease based on history, imaging and spirometry by a lung specialist 40 years no limit Both Diabetic patients Kidney failure, GFR<30 Serum potassium > 5.2 Liver dysfunction (AST or ALT more than three times the upper limit of normal and biliary cirrhosis and cholestasis) Active malignancy Patient undergoing chemotherapy or immunotherapy Pregnancy and breastfeeding EF<50% History of cardiovascular diseases including more than mild mitral valve insufficiency, more than mild aortic valve insufficiency Left ventricular diastolic failure more than mild, any valvular stenosis in echo and the presence of other causes of right ventricular failureHistory of PHTN such as hypothyroid and hyperthyroid and connective tissue diseases and blood diseases such as thalassemia anemic, tuberculosis, splenectomy and HIV Patients who were hospitalized in the intensive care unit or underwent intubation before the start of the study J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Treatment - Other Intervention group:Daily use of empagliflozin 10 mg orally manufactured by an Iranian pharmaceutical company for a maximum of 3 months after discharge Control group: It will include patients who meet the inclusion criteria but do not receive any intervention and are only under standard medical care according toThe clinical trial protocol will be monitored and followed up for a maximum of three months after discharge from the hospital The rate of acute attacks of COPD during three months after the intervention by empagliflosine group and control group. Timepoint: During three months from the beginning of the study to the end of the study. Method of measurement: visit,history,checklist. Investigation and comparison of severity of acute attacks of COPD during three months after the intervention by empagliflosine group and control group. Timepoint: During three months from the beginning of the study to the end of the study. Method of measurement: visit,history,checklist. Investigating and comparing the mortality rate of COPD patients within three months after the intervention, separately from the empagliflosine group and the control group. Timepoint: During three months from the beginning of the study to the end of the study. Method of measurement: visit,history,checklist. Investigation and comparison of changes in echocardiographic criteria and RV function in non-diabetic COPD patients during three months after the intervention by groupempagliflosine and control group. Timepoint: The beginning of the study and 3 months after that. Method of measurement: echocardiography. Shahid Beheshti University of Medical Sciences Approved 2024-06-18 School of Medicine - Shahid Beheshti University of Medical Sciences South hassan bana Ave Tehran Tehran Iran (Islamic Republic of)