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Conditions
Interventions
Intervention 1: Intervention group: Patients who meet the inclusion and exclusion criteria will be randomly assigned to either the standard control or intervention group (empagliflozin 10 mg tablet ad
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age of 18 to 75 yr Having Right Heart Catheterization before participation in trial Obtaining informed patinet Consent Patients with Pulmonary Arterial Hypertension group 1 (PAH)
Exclusion criteria
Exclusion criteria: Severe Renal failure (GFR=20 ml/min/1.73m2) Pregnancy and Breastfeeding Hypersensitivity to SGLT2 inhibitors Need for Surgery (which temporary discontinuation of Empagliflozin is necessary at least 3 days prior to surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased distance in the 6-minute walk test. Timepoint: Baseline and after 3 months after drug or Placebo. Method of measurement: Measuring pulse, blood pressure, blood oxygen, and respiration before starting the 6-minute walking test and recording the distance traveled in 6 minutes.;Right ventricular functional indices based on right heart catheterization (including atrial intracardiac pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output, mixed venous oxygen saturation, and cardiac index). Timepoint: Right ventricular functional indices based on right heart catheterization (including atrial intracardiac pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output, mixed venous oxygen saturation, and cardiac index). Method of measurement: The Physician will assess the patient's condition and prescribe sedatives if necessary. To insert the catheter, a local anesthetic is applied to the area where the catheter will be inserted (to femoral vein) and the catheter is inserted into the body through a vein. This will measure the pressure in the right atrium, right ventricle, and the pulmonary artery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiographic findings (including left atrial size at end-diastole, left ventricular function at end-systole (ejection fraction) (%), 'E/E ratio, right ventricular size at end-diastole, TAPSE, RVOT acceleration time index, systolic pulmonary artery pressure, right atrial area, pericardial effusion (fluid around the heart)), comparison of lung function class, biochemical tests including complete blood cell count, blood urea nitrogen, bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine, sodium, potassium, hemoglobin, and uric acid. Timepoint: Baseline and 3 months after taking drug or placebo. Method of measurement: Electrodes are attached to the patient's chest while they are lying on their back to record the electrical activity of the heart. After applying a special gel to the patient's chest that transmits sound waves well, a probe (transducer) generates sound waves, which are radiated onto the chest and moved slowly. The sound waves pass through the heart and are reflected. These waves are received by the device and converted into moving images of the heart. It evaluates the structure and function of the heart. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactzahra kolahdooz
Mashhad University of Medical Sciences
Outcome results
None listed