Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Brigham and Women's Hospital115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

115

Conditions

Pulmonary Hypertension

Interventions

Vasodilator testing (Inhaled Nitric Oxide)DRUG

Right heart catheterization with vasodilator testing with each arms' associated agent will be performed

Vasodilator testing (Inhaled Epoprostenol)DRUG

Right heart catheterization with vasodilator testing with each arms' associated agent will be performed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.

Data from ClinicalTrials.gov

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