Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

NCT04231084 | Completed Phase 4 FDA Drug

• 1 other identifier: 2019P003491
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

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.

  Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.

Study Arms (2)

Inhaled Nitric Oxide

ACTIVE COMPARATOR

Vasodilator testing will be performed with inhaled nitric oxide

Drug: Vasodilator testing (Inhaled Nitric Oxide)

Inhaled Epoprostenol

EXPERIMENTAL

Vasodilator testing will be performed with inhaled epoprostenol

Drug: Vasodilator testing (Inhaled Epoprostenol)

Interventions

Vasodilator testing (Inhaled Nitric Oxide) DRUG

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

Inhaled Nitric Oxide

Vasodilator testing (Inhaled Epoprostenol) DRUG

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

Inhaled Epoprostenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aaron B Waxman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pulmonary and Critical Care

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: January 15, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once study completion achieved

Locations

US (1)