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IRCT20230804059027N1 IRCT 2023-08-12 Tehran University of Medical Sciences Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, Tehran: a randomized, double-blind clinical trial 2023-08-07 anticipated 46 Complete https://irct.ir/trial/71817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups receiving inhaled verapamil and placebo. The method of randomization is based on the randomization table designed on the basis of blocks of 4, so that the patient's doctor knows how to intervene in patients, but the echocardiologist colleague and the colleague responsible for recording clinical information and echo parameters do not know about the intervention, Blinding description: In this study, patients with COPD are selected based on GOLD clinical criteria, spirometric characteristics, and the presence of clinical symptoms by respected professors specializing in pulmonary diseases. Then the patients are divided into two groups receiving inhaled verapamil and placebo. The method of randomization is based on the randomization table designed on the basis of blocks of 4, so that the attending physician (clinical caregiver) knows how to intervene in patients, but the echocardiologist colleague and the colleague responsible for recording clinical information and echo parameters as well The co-analysts of the data are not aware of the clinical intervention. 3 chronic obsrtuctive pulmonary disease. Intervention 1: Intervention In the intervention group: with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital in this group, verapamil in the form of inhalation and in the amount of 10 mg with a dilution of 2.5 mg/mL with a volume of 4 cc by Ultrasonic Nebulier CUN60 device once every 12 hours for 72 hours and in A total of 60 mg is prescribed. Intervention 2: Control group: In the control group: patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, distilled water (placebo) was administered by inhalation in the amount of 4cc by Ultrasonic Nebulier CUN60 every 12 hours for 72 hours and a total of 24cc. . Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals. The specific title of the documentation is the relationship between inhaled verapamil and pulmonary artery pressure in COPD patients . When: The access period starts one year after the results are published. To whom: It is possible to access the data for all researchers working in academic and scientific institutions as well as people working in the industry. Conditions: There are no other conditions and restrictions for the use of data. Where to obtain: Visiting the library of Imam Khomeini Hospital and the library of the Faculty of Medicine of Tehran University of Medical Sciences. Email address : 1- sardaricardio@gmail.com 2- Dr.K.Gharloghi@gmail.com How to obtain: The applicant can access the data files by providing valid documents for scientific research or industry-related work. Comments:
public Dr. Kazem Gharloghi
Imam Khomeini Hospital., Doctor Gharib Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2762 Dr.K.Gharloghi@gmail.com Tehran University of Medical Sciences scientific Dr Akram Sardari
Imam Khomeini Hospital., Doctor Gharib Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2762 sardaricardio@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with proven chronic obstructive pulmonary disease based on spirometry criteria and patient history Patients with proven chronic obstructive pulmonary disease and hospitalized in Imam Khomeini Hospital no limit no limit Both Valvular heart disease more than moderate Pulmonary valve stenosis History of renal failure History of liver cirrhosis History of pulmonary embolism Congenital heart disease I27.2 Other secondary pulmonary hypertension Treatment - Drugs Treatment - Drugs Intervention In the intervention group: with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital in this group, verapamil in the form of inhalation and in the amount of 10 mg with a dilution of 2.5 mg/mL with a volume of 4 cc by Ultrasonic Nebulier CUN60 device once every 12 hours for 72 hours and in A total of 60 mg is prescribed. Control group: In the control group: patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, distilled water (placebo) was administered by inhalation in the amount of 4cc by Ultrasonic Nebulier CUN60 every 12 hours for 72 hours and a total of 24cc. . Pulmonary artery systolic pressure reduction. Timepoint: Pulmonary artery systolic pressure was measured by echocardiography at the beginning of the study (before the intervention) and 1 hour after receiving inhaled verapamil. Method of measurement: Echocardiography device Affiniti 50. The increase in oxygen saturation of arterial blood. Timepoint: Arterial blood oxygen saturation is measured before receiving inhaled verapamil (pre-intervention) and 1 hour after the intervention. Method of measurement: Measurement of arterial blood oxygen saturation is done by finger pulse oximeter. Tehran University of Medical Sciences Approved 2022-11-15 Ethics commitee of Tehran Uninersity of Medical Sciences Imam Khomeini Hospital., Doctor Gharib Street Tehran Tehran Iran (Islamic Republic of)