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IRCT20200209046427N2 IRCT 2023-08-18 Shahid Beheshti University of Medical Sciences Dapagliflozin in Pulmonary Arterial Hypertension Effectiveness of Dapagliflozin on Cardiovascular Outcomes and Quality of Life in Pulmonary Arterial Hypertension Patients 2023-09-23 anticipated 100 Complete https://irct.ir/trial/71446 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is designed to randomize subjects into groups that result in equal sample sizes and to ensure a balance in sample size across groups over time. Patients will be entered into the study groups by simple randomization in a 1:1 ratio (intervention to control ratio) and in blocks of 4. The investigators ensure unpredictability of the allocation sequence and by using a computerized random number generation process. By using this central randomization, the random allocation sequence will remain concealed from those enrolling patients into the study, Blinding description: People involved in the trial including participants(patients), principle investigator particularly investigator initiated trial, healthcare providers (Physicians, nurses, etc.), who care for participants during the trial, data collectors, and outcome assessors and data saftey and monitoring board do not know if the recipient is receiving the actual drug or placebo and all of them are blinded. Dapagliflozin tablets 10 mg from Actover company in both intervention and placebo groups are completely similar in terms of color, shape, smell, size and method of administration. Drugs will be delivered to patient as A or B in the same shape, and nobody knows which of them is true drug and which of them is placebo. 2 Pulmonary arterial hypertension. Intervention 1: Intervention group: Dapagliflozin (Sodium-glucose co-transporter-2 (SGLT2) inhibitors with a dose of 10 mg/daily from Actover company for 3 months. Intervention 2: Control group: Placebo of Dapagliflozin one tablet/daily from Actover company for 3 months. Yes - There is a plan to make this available What will be shared: All collected deidentified patient`s documents can be available. When: Documents files will become available 6 months after publication up to one year To whom: Documents would be available for people working in academic institutions and people working in businesses after applying to receive it. Conditions: Documents would be available according to cause of request. Where to obtain: shafaghishadi@yahoo.com Documents would be available according to cause of request. Shadi Shafaghi How to obtain: It is necessary for the applicant to send an e-mail to the researcher and write the reason for requesting access to the data. If confirmed, the information will be sent within a week. Comments:
public Shadi Shafaghi
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3810 shafaghishadi@Yahoo.Com Shahid Beheshti University of Medical Sciences scientific Babak Sharif Kashani
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3810 Babaksharifkashani@Yahoo.Com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age > or = 18 PAH, class of 1 & 4 based on guideline In the case of group 4 PH, the patient should not be candidate for endarterectomy or balloon angioplasty during project NYHA Functional Class >1 Clinically stable patients on pulmonary vasodilator treatment and treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening. Literacy Informed consent 18 years no limit Both Allergy to SGLT2i treatment with SGLT2i in last 6 months PAH 2, 3, 5 eGFR <30 Severe liver dysfunction (Child-Pugh Class C) Lung transplant candidate Type 1 diabetes Severe Urinary or vaginal infection I27. 0 Primary pulmonary hypertension Treatment - Drugs Placebo Intervention group: Dapagliflozin (Sodium-glucose co-transporter-2 (SGLT2) inhibitors with a dose of 10 mg/daily from Actover company for 3 months Control group: Placebo of Dapagliflozin one tablet/daily from Actover company for 3 months Pro- Brain natriuretic peptide (Pro-BNP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Laboratory data (Blood Sample). The 6-minute walk test (6MWT) test. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Treadmill. New York Heart Association (NYHA) functional class. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Taking History approved by physician. Health Related Quality of Life. Timepoint: First day, 3 months later at the randomization time. Method of measurement: EmPHasis-10 Health Related Quality of life questionnaire. Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography. Tricuspid annular plane systolic excursion (TAPSE). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography. Tricuspid annular plane systolic excursion (TAPSE) / Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography. Right ventricle (RV) Size. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography. Pericardial effusion. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography. Shahid Beheshti University of Medical Sciences Approved 2023-08-13 Iran National Committee for Ethics in Biomedical Research Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout Tehran Tehran Iran (Islamic Republic of)