A clinical trial to study the effects of Tadalafil in patients with pulmonary hypertension.
Phase 3
- Registration Number
- CTRI/2009/091/000744
- Lead Sponsor
- Division of Cardiology,Department of Medicine,Mahatma Gandhi Memorial Medical College and M.Y.Hospital,Indore,India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
symptomatic patients >= 18 year of age with WHO Group I PAH
-Associated PAH:
congenital L -->R shunt
Exclusion Criteria
Contraindication for Tadalafil or PDE-5 inhibitors,
Other WHO PAH Group (II, III, IV, V),
Patient not able to give informed consent,
Participation in another PAH trial or other trial (current or within one month of completion),
Patients with neuromuscular or orthopedic condition not permitting active participation,
with other medical illness limiting life expectancy < 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6 minute walk testTimepoint: baseline,1 month and 3monthly till 36 months.;Quality of life (EQ-5D)Timepoint: baseline,1 month and 3monthly till 36 months.;WHO Functional ClassTimepoint: baseline,1 month and 3monthly till 36 months.
- Secondary Outcome Measures
Name Time Method Composite of 6MWD/WHO functional class/ EQ-5DTimepoint: at the end of 3 months, 12 months, 24 months and 36 months.;Event free survival at end of 36 months. This includes freedom from all cause deaths,PAH related hospitalization,need for addition of another PAH specific therapies or atrial septostomy or heart/lung transplantation.Timepoint: at the end of 3 months, 12 months, 24 months and 36 months.