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OpenTrials
Completed

NCT Number: NCT04231084

Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

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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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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