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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT04194632
Eligibility Criteria:
Inclusion Criteria:
* Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with diagnosed pulmonary arterial hypertension.
* Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization
* Functional class 2 or 3 symptoms
* Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements
* English speaking
* All patients will be required to have evidence of right ventricular hypertrophy or conduction delay (QRS \> 130ms) on surface ECG
Exclusion Criteria:
* Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
* Functional class 4 symptoms
* Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
* Contraindication to right heart catheterization including significant thrombocytopenia (platelets \< 50,000), coagulopathy (INR \> 1.8), or pregnancy as determined by routine screening laboratory work
* Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure
* Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure
* Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram.
* Left ventricular dysfunction (EF \< 50%) as determined by baseline transthoracic echocardiogram.
* Inability to complete cardiac MRI or transthoracic echocardiography
* Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension
* Patients otherwise deemed not appropriate for the study as determined by the study investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04194632
Study Brief:
Protocol Section:
NCT04194632