Health Condition 1: I272- Other secondary pulmonary hypertension
Conditions
Interventions
Intervention1: TADALAFIL: TADALAFIL 40mg once a day for 6 months
Control Intervention1: SILDENAFIL: SILDENAFIL 20mg three times a day for 6 months
Sponsors
Midhun Sakravarthy J
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender 2. Aged more than 18 years 3. Patients who are diagnosed with Pulmonary Hypertension based on 2D-Echo having any pulmonary etiology (Group 3) not on any pulmonary vasodilator therapy and WHO Functional Class II-III
Exclusion criteria
Exclusion criteria: 1. Impaired hepatic Function with elevated AST or ALT levels = 3 times the upper limit of normal 2. Patient with history of renal disease or impaired kidney function with elevated Serum creatinine 3. Pregnant and lactating women 4. Patients requiring nitrate therapy for any clinical indication. 5. Contraindication to Tadalafil or Sildenafil use including allergy to any PDE-5 inhibitor, anatomical deformations of the penis, sickle cell anemia, multiple myeloma, leukemia, bleeding disorders, active peptic ulcer disease, retinitis pigmentosa or other retinal disorders 6. The use or anticipated use of any of the following drugs: any nitrate, protease inhibitor, anti-fungal agent and/or rifampin, or doxazosin. 7. Known malignancies 8. Known other heart related co-morbid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in 2D-Echo parameters (RVSP, TRJET) 2. Change in Six-Minute Walk distance TestTimepoint: 1.0,3rd and 6th month 2.0,3rd and 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Arterial Blood Gas(PaO2) 2.Change in WHO-Functional class for pulmonary hypertensive patients 3.Adverse reactionsTimepoint: 1.0,3rd and 6th month 2.0,3rd and 6th month 3.0,3rd and 6th month | — |
Countries
India
Contacts
Public ContactMehdi Ali Mirza
ESIC Medical College and Hospital
Outcome results
None listed