Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Pulmonary Hypertension Clinical Trial

Official title:

Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231084
• Other study ID #: 2019P003491
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Eileen M Harder, MD
• Phone: 617-525-9733
• Email: eharder1[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mPAP = 21mmHg, PAWP = 25mmHg, and PVR =3 WU

• Classified as WHO group I-III pulmonary hypertension

Exclusion Criteria:

• WHO group IV and V pulmonary hypertension

• Patients who are on baseline pulmonary vasodilator medications

• Severe aortic or mitral valve disease

• Patients who are pregnant

• Left ventricular ejection fraction of <35%

• Patients who are hospitalized as inpatients at the time of RHC

• Patients with systolic blood pressure <90mmHg or mean arterial pressure of < 60mmHg

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Vasodilator testing (Inhaled Nitric Oxide)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
• Vasodilator testing (Inhaled Epoprostenol)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean pulmonary artery pressure	The primary outcome will be change in mean pulmonary artery pressure (mmHg) from baseline to after 5-minutes of inhaled vasodilator.	Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.