Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

August 5, 2024 updated by: Aaron Waxman MD PhD, Brigham and Women's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Inhaled Nitric Oxide
Vasodilator testing will be performed with inhaled nitric oxide
Drug: Vasodilator testing (Inhaled Nitric Oxide)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
Experimental: Inhaled Epoprostenol
Vasodilator testing will be performed with inhaled epoprostenol
Drug: Vasodilator testing (Inhaled Epoprostenol)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean pulmonary artery pressure
Time Frame: 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.
Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Aaron B Waxman, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P003491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Once study completion achieved

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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