Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension

NCT03044314 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00075840
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pulmonary hypertension; vasodilator challenge; echocardiography; outcomes; iloprost; inhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

• Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost

  Baseline and approximately 30 minutes

Secondary Outcomes (4)

• Percent Change in Systolic Pulmonary Arterial Pressure After Vasodilator Challenge

  Baseline and during vasodilator inhalation, approximately 30 minutes

• Number of Participants Who Respond After Vasodilator Challenge

  Baseline and during vasodilator inhalation, approximately 30 minutes

• Number of Participants With Clinical Response to Vasodilator Challenge by Echo

  Baseline, approximately 30 minutes, 3 months, and 12 months

• Association of Change in Pressures After Vasodilator Challenge With Clinical Outcomes

  3 months and 12 months

Study Arms (1)

Iloprost and nitric oxide administration

EXPERIMENTAL

Each patient will receive 40 ppm inhaled nitric oxide and 2.5-5 mcg inhaled iloprost in the catheterization laboratory with assessment of hemodynamic response. Patients will also receive 2.5-5 mcg iloprost during echocardiographic assessment.

Drug: Iloprost and nitric oxide administration

Interventions

Iloprost and nitric oxide administration DRUG

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.

Also known as: Ventavis

Iloprost and nitric oxide administration

Eligibility Criteria

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

You may qualify if:

• Adult patients no younger than 18 years of age
• Recently diagnosed pulmonary hypertension (defined by RV systolic pressure of ≥ 40 mmHg as measured by echocardiography), going for invasive hemodynamic assessment for pulmonary hypertension
• Normal left ventricular function defined as a left ventricular ejection fraction (LVEF) greater than or equal to 50%

You may not qualify if:

• Heart failure (LVEF \< 50%, diastolic dysfunction \> stage 1, history or symptoms of left heart failure) - Group II pulmonary hypertension
• + or higher MR or AI
• Inadequate echocardiographic windows
• Pregnancy
• Systolic blood pressure ≤ 90 mmHg

Sponsors & Collaborators

• Duke University: lead
• Actelion: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Richard Krasuski
• Organization: Duke University Medical Center

richard.krasuski@duke.edu

919-681-6195

Study Officials

• Richard A Krasuski, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: February 7, 2017
• Study Start: July 21, 2017
• Primary Completion: June 20, 2019
• Study Completion: May 19, 2020
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)