Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Phase 4

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Vasodilator testing (Inhaled Nitric Oxide); Drug: Vasodilator testing (Inhaled Epoprostenol)

• Registration Number: NCT04231084
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2021-01-15
• Status Verified: 2023-02
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhaled Nitric Oxide	Vasodilator testing (Inhaled Nitric Oxide)	Vasodilator testing will be performed with inhaled nitric oxide
Inhaled Epoprostenol	Vasodilator testing (Inhaled Epoprostenol)	Vasodilator testing will be performed with inhaled epoprostenol

Primary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States