Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-24 @ 9:35 PM
NCT ID:
NCT01200732
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01200732
Study Brief:
Protocol Section:
NCT01200732