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CompletedNCT04231084Updated Aug 6, 2024

Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

A Phase 4 interventional study of Vasodilator testing (Inhaled Nitric Oxide) and Vasodilator testing (Inhaled Epoprostenol) in Pulmonary Hypertension, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 115 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
  • Classified as WHO group I-III pulmonary hypertension

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Active comparator
    Inhaled Nitric Oxide

    Vasodilator testing will be performed with inhaled nitric oxide

    Drug: Vasodilator testing (Inhaled Nitric Oxide)

  • Experimental
    Inhaled Epoprostenol

    Vasodilator testing will be performed with inhaled epoprostenol

    Drug: Vasodilator testing (Inhaled Epoprostenol)

Interventions

  • DrugVasodilator testing (Inhaled Nitric Oxide)

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

  • DrugVasodilator testing (Inhaled Epoprostenol)

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

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04231084
Lead sponsor
Brigham and Women's Hospital
Responsible party
Aaron Waxman MD PhD (Associate Professor of Pulmonary and Critical Care, Brigham and Women's Hospital) — Principal investigator
First posted
Jan 18, 2020
Start date
Jan 15, 2021
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024
Last update
Aug 6, 2024

Study contacts

Aaron B Waxman, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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