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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT01889966
Eligibility Criteria:
Inclusion Criteria:
* Precapillary pulmonary hypertension associated with connective tissue disease
* resting mean pressure in the pulmonary artery of \> 24 mmHg
* resting mean pulmonary capillary wedge pressure (PCWP) of \< 16 mmHg
* age 18 to 80 years
* women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception
* women must not be breastfeeding
* ability to understand and sign the informed consent, correctly signed informed consent
Exclusion Criteria:
* pretreatment with Sildenafil
* contraindications for Sildenafil treatment:
* known intolerance to Sildenafil,
* optic neuropathy (NAION),
* known hereditary retina disease,
* need of nitrate therapy
* advanced liver cirrhosis - CHILD C
* severely reduced renal function with GFR \< 30 ml/min/1,73 m²
* stroke or myocardial infarction within the last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01889966
Study Brief:
Protocol Section:
NCT01889966