Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Nitric Oxide

Vasodilator testing will be performed with inhaled nitric oxide

Group Type ACTIVE_COMPARATOR

Vasodilator testing (Inhaled Nitric Oxide)

Intervention Type DRUG

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

Inhaled Epoprostenol

Vasodilator testing will be performed with inhaled epoprostenol

Group Type EXPERIMENTAL

Vasodilator testing (Inhaled Epoprostenol)

Intervention Type DRUG

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

Interventions

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Vasodilator testing (Inhaled Nitric Oxide)

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

Intervention Type DRUG

Vasodilator testing (Inhaled Epoprostenol)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No