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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04554160
Eligibility Criteria:
Inclusion Criteria:
* Pulmonary hypertension patients \>18 years of age
* Voluntary participation after giving informed verbal and written consent
* Patients naïve to PAH-specific treatments
* Patients on current PAH specific medication independent of duration of therapy
* Patients can be in WHO group 1 classified by one of the following subgroups:
* Idiopathic pulmonary arterial hypertension (IPAH)
* Heritable pulmonary arterial hypertension (HPAH)
* Drugs and toxins
* Associated with (APAH): specifically, connective tissue disease (CTD), HIV infection and congenital heart disease
* Patients with chronic thromboembolic pulmonary hypertension
* Diagnosis of PAH confirmed by right heart catheterization
* WHO/NYHA functional class II to IV symptoms
* 6MWT distances of ≥50 meters and within 15% of each other on 2 consecutive tests preferably performed on different days during Screening.
Exclusion Criteria:
* Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at Screening: BMI \>30 kg/m2; diabetes mellitus of any type; systemic hypertension, significant coronary artery disease; or left atrial volume index (LAVi) \>30 mL/m2.
* Evidence or history of left-sided heart disease and/or clinically significant cardiac disease.
* Acutely decompensated heart failure within 30 days prior to Screening
* Evidence of significant parenchymal lung disease
* Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (SBP) \>160 mmHg or sitting diastolic blood pressure (DBP) \>100 mmHg at Screening. • Systolic blood pressure \>160 mmHg or \< 90 mmHg; or diastolic blood pressure \> 100 mgHg at Screening
* Male subjects with a corrected QT interval using Fridericia's formula (QTcF) \>450 msec, and female subjects with QTcF \>470 msec on ECG measured at Screening or Baseline.
* Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04554160
Study Brief:
Protocol Section:
NCT04554160