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Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Primary Purpose

Pulmonary Hypertension

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vasodilator testing (Inhaled Nitric Oxide)
Vasodilator testing (Inhaled Epoprostenol)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Inhaled Nitric Oxide

Inhaled Epoprostenol

Arm Description

Vasodilator testing will be performed with inhaled nitric oxide

Vasodilator testing will be performed with inhaled epoprostenol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
February 25, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04231084
Brief Title
Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
Official Title
Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide
Arm Type
Active Comparator
Arm Description
Vasodilator testing will be performed with inhaled nitric oxide
Arm Title
Inhaled Epoprostenol
Arm Type
Experimental
Arm Description
Vasodilator testing will be performed with inhaled epoprostenol
Intervention Type
Drug
Intervention Name(s)
Vasodilator testing (Inhaled Nitric Oxide)
Intervention Description
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
Intervention Type
Drug
Intervention Name(s)
Vasodilator testing (Inhaled Epoprostenol)
Intervention Description
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
Primary Outcome Measure Information:
Title
Change in mean pulmonary artery pressure
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen M Harder, MD
Phone
617-525-9733
Email
eharder1@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron B Waxman, MD
Phone
617-525-9733
Email
abwaxman@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron B Waxman, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron B Waxman, MD, PhD
Phone
617-525-9733
Email
abwaxman@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Eileen M Harder, MD
Phone
617-525-9733
Email
eharder1@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Eileen M Harder, MD
First Name & Middle Initial & Last Name & Degree
Aaron B Waxman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Once study completion achieved

Learn more about this trial

Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

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