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Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04231084
Enrollment
115
Registered
2020-01-18
Start date
2021-01-15
Completion date
2024-08-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

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

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in mean pulmonary artery pressurePre-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026