Status:
COMPLETED
Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Eisenmenger Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmeng...
Detailed Description
Methods Patients of ES with age greater than or equal to 18 years and weight greater than or equal to 30 kgs in World Health Organisation (WHO) functional class II and III attending our congenital cli...
Eligibility Criteria
Inclusion
- Patients of ES with age greater than or equal to 14 years and weight greater than or equal to 30 kgs in World Health Organisation (WHO) functional class II and III attending our congenital clinic were invited to participate in the study
Exclusion
- WHO class IV,
- congestive heart failure or had PCWP \> 15mmHg,
- left ventricular ejection fraction \<40%,
- atrial fibrillation,
- patent ductus arteriosus,
- complex congenital heart defects,
- restrictive lung disease(total lung capacity \< 70% of predicted), obstructive lung disease ( forced expiratory volume in 1 second \[FEV1\] \< 70% of predicted with FEV1/ Forced vital capacity \[FVC\] \< 60%),
- previously diagnosed coronary artery disease requiring nitrate therapy,
- abnormal biochemical profile and
- hypersensitivity to PDE- 5 inhibitors.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01200732
Start Date
February 1 2008
End Date
July 1 2010
Last Update
September 14 2010
Active Locations (1)
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1
Govind Ballabh Pant Hospital(GB Pant Hospital)
New Delhi, New Delhi, India, 110002