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Vasodilators for Pulmonary Hypertension

Phase 4
Recruiting
Led By Aaron B Waxman, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Classified as WHO group I-III pulmonary hypertension
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
Awards & highlights

Study Summary

This trial is testing two drugs to see how they affect blood vessels in people with pulmonary hypertension.

Who is the study for?
This trial is for people with certain types of pulmonary hypertension (high blood pressure in the lungs), specifically WHO groups I-III. Participants must have specific measurements of lung and heart function to join. Pregnant individuals, those with severe heart valve disease, very low blood pressure, or advanced stages of pulmonary hypertension cannot participate.Check my eligibility
What is being tested?
The study is testing how well two different inhaled medications—Nitric Oxide and Epoprostenol—work to widen blood vessels in the lungs and improve blood flow. It aims to understand their effects on various forms of pulmonary hypertension and how they relate to disease severity.See study design
What are the potential side effects?
Inhaled Nitric Oxide may cause headaches, dizziness, or nausea; it can also lead to airway inflammation or bleeding if used long-term. Inhaled Epoprostenol might result in similar side effects like headache, jaw pain, nausea but can also include risks such as flushing or decreased blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pulmonary hypertension is classified as WHO group I-III.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean pulmonary artery pressure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Inhaled EpoprostenolExperimental Treatment1 Intervention
Vasodilator testing will be performed with inhaled epoprostenol
Group II: Inhaled Nitric OxideActive Control1 Intervention
Vasodilator testing will be performed with inhaled nitric oxide

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,470,219 Total Patients Enrolled
Aaron B Waxman, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Vasodilator testing (Inhaled Epoprostenol) Clinical Trial Eligibility Overview. Trial Name: NCT04231084 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
Aaron Waxman MD PhD 2021. "Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04231084.
All > High Blood Pressure > Pulmonary Hypertension
~16 spots leftby Dec 2024
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