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Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension

NCT03044314 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-04-02

Study results available
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Summary

This study will compare the clinical efficacy of inhaled iloprost as an invasive, selective vasodilator in the cardiac catheterization laboratory in patients with pulmonary hypertension to the gold standard of inhaled nitric oxide. It will also examine whether echocardiographic estimates of response to inhaled iloprost can predict responsiveness to invasive vasodilator testing in patients with pulmonary hypertension.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Iloprost and nitric oxide administration

Iloprost will be administered by the I-neb ultrasonic nebulizer (Respironics, Cedar Grove, New Jersey) with a disposable attachment that allows for administration to a supine patient at a concentration of 10 µg/ml with a 10 minute dose of 2.5 µg and then repeated to a cumulative dose of 5.0 µg if tolerated.

Sponsors & Collaborators

Principal Investigators

  • Richard A Krasuski, MD · Duke Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2019-06-20
Completion
2020-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044314 on ClinicalTrials.gov