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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT01121458
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent before initiation of any study related procedures.
* 21 years of age or older
* Referred for clinically indicated pulmonary vascular resistance assessment
* Presence of pulmonary hypertension by non-invasive testing
* Patients referred for RHC and vasoreactivity testing
Exclusion Criteria:
* Patient with baseline SBP \< 100 mmHg
* Patient with HR\>120 beats/minute
* Patients with severe or valvular heart disease
* Patients with an acute coronary syndrome
* Patients with a creatinine clearance \< 30 ml/min
* Patients with class IV congestive heart failure
* Patients with platelet count \< 100,000 per cc3
* Patients with hemoglobin \< 10g/dl
* Patient with INR \> 1.5
* Patients with positive pregnancy test - women between 21 and 60 years of age
* Patients with known or suspected allergy to study drug or study drug components, including allergy to soybeans, soy products, eggs, or egg products
* Patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia
* Patients with contraindications to the use of IV nitroprusside
* Patients with diagnosed or suspected intra-cardiac or systemic arteriovenous shunts
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 3 months of randomization.
* Other medical conditions that, in the opinion of the investigator, preclude participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01121458
Study Brief:
Protocol Section:
NCT01121458