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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02885012
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a Connective Tissue Disease (CTD)
* Age range: 18-80 years old
* Previous Right Heart Catheterization (RHC) demonstrating PAH
* Forced vital capacity (FVC) greater than 50%
* Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
* World Health Organization (WHO) functional class II or III
* Able to perform a 6 minute walk test (6MWT)
* Stable dose of antihypertensive medications
* Non-pregnant females
* Have to be currently on stable dose of bosentan for at least 3 months
* Adequate acoustic images to allow for transthoracic echocardiography to be performed
Exclusion Criteria:
* Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
* Severe systemic hypertension greater than 170/95
* Patients with a prior history of cardiovascular disease
* WHO functional class IV status
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
* FVC less than 50% of predicted
* DLCO less than 50% of predicted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02885012
Study Brief:
Protocol Section:
NCT02885012