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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT02305550
Eligibility Criteria:
FIRST PART OF THE STUDY: HEALTHY VOLUNTEER STUDY (n=6 volunteers)
Inclusion Criteria:
* Have a government photo identity card;
* Age \< 40 years old;
* Body mass index (BMI) \<28 kg/m2 and \>18 kg/m2;
* Feel well the day of nitric oxide testing;
* Normal physical exam
Exclusion Criteria:
* Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
* Systemic disease with or without any functional limitation; including controlled hypertension and controlled diabetes without systemic effects;
* Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
* Active smoking, volunteers may be enrolled if they quit smoking for more than 1 year;
* Excess alcohol use: more than ½ L/day of wine consumption or equivalent;
* Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives;
* Currently enrolled in another research study.
SECOND PART OF THE STUDY: CATH-LABORATORY STUDY (n=6 cath laboratory subjects)
Inclusion criteria:
* Have a government photo identity card;
* Diagnosis of Pulmonary Arterial Hypertension, Group I, III, IV and V, as defined by the National Heart Lung and Blood Institute classification.
* Known positive responder to inhaled nitric oxide
* Wedge pressure ≤15 mmHg at baseline
* Pulmonary arterial pressure (mean) greater than or equal to 40 mmHg
* Scheduled Cath Lab testing for right heart catheterization to assess pulmonary vasodilator capacity
Exclusion Criteria:
* Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
* Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
* Left ventricular failure for which breathing nitric oxide is contraindicated;
* Patients with diagnosis of congenital or acquired methemoglobinemia reductase deficiency;
* Currently enrolled in another research study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02305550
Study Brief:
Protocol Section:
NCT02305550