Clinical trial NCT03044314: Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension
Official title: Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension (The OVATION Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
vasodilator challenge
echocardiography
outcomes
iloprost
inhaled nitric oxide
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2017-02-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Iloprost was the first inhaled prostacyclin analogue to be FDA-approved for the treatment of pulmonary arterial hypertension. Iloprost aerosol has been shown to significantly improve pulmonary hemodynamics in patients with idiopathic pulmonary hypertension (PH), with an effect greater than nitric oxide and sildenafil. It has also been shown to be more effective than nitric oxide at reducing pulmonary arterial pressure (PAP) than prostacyclin infusion when used in the cardiac catheterization laboratory. Because of its administration through inhalational means, iloprost has the advantage of selective action on the pulmonary vasculature with avoidance of the systemic side effects that plague many of the other treatments for PH. The investigators intend to compare the efficacy of inhaled iloprost in reducing pulmonary artery pressure to the gold standard of nitric oxide in patients with pulmonary hypertension.

Without an established noninvasive algorithm to identify beneficial hemodynamic response to vasodilators, patients with pulmonary hypertension (PH) are routinely subjected to expensive and invasive testing. Echocardiography is routinely used to facilitate a diagnosis of PH and a few echocardiographically-derived estimates have even been shown to correlate with vasodilator responsiveness and survival. Dynamic, real time changes in echocardiographic parameters have not been previously evaluated as a predictor of vasodilator responsiveness or of clinical outcome. The investigators will examine whether echocardiographic changes in response to inhaled iloprost can predict invasively derived vasodilator responsiveness and help assess prognosis in patients with pulmonary hypertension, possibly even obviating the need for invasive testing.

Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost
timeFrame: Baseline and approximately 30 minutes
Secondary outcomes:
measure: Percent Change in Systolic Pulmonary Arterial Pressure After Vasodilator Challenge
timeFrame: Baseline and during vasodilator inhalation, approximately 30 minutes
measure: Number of Participants Who Respond After Vasodilator Challenge
timeFrame: Baseline and during vasodilator inhalation, approximately 30 minutes
measure: Number of Participants With Clinical Response to Vasodilator Challenge by Echo
timeFrame: Baseline, approximately 30 minutes, 3 months, and 12 months
measure: Association of Change in Pressures After Vasodilator Challenge With Clinical Outcomes
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Richard A Krasuski, MD
role: PRINCIPAL_INVESTIGATOR
References: