Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension (OVATION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03044314|
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Illoprost and nitric oxide administration||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||OUTPATENT VASODILATOR ASSESSMENT USING ILOPROST IN PULMONARY HYPERTENSION (The OVATION Study)|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Iloprost and nitric oxide administration
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: Illoprost 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.
Other Name: Ventavis
- Change in invasively measured pulmonary artery pressures after challenge with NO and iloprost [ Time Frame: Baseline and approximately 30 minutes ]Compare the percent change in the invasively measured PAP after challenge with NO compared to the percent change in invasively measured PAP after challenge with iloprost.
- Change in echocardiographic and invasively measured parameters after vasodilator challenge [ Time Frame: Baseline and approximately 30 minutes ]Compare the percent change in echocardiographic parameters measured after vasodilator challenge with percent change of invasively measured vasodilator response.
- Change in PA pressure and mean pressure determined invasively after vasodilator challenge [ Time Frame: Baseline and approximately 30 minutes ]Dichotomize the vasodilator response into responders and nonresponders, based on a 10 mmHg drop in PA pressure and a mean pressure <40mmHg determined invasively. Receiver operating characteristic (ROC) curves will evaluate the echocardiographic parameters for prediction of vasodilator response.
- Clinical response to vasodilator challenge by echo [ Time Frame: Baseline, approximately 30 minutes, 3 months, and 12 months ]Measure the clinical response to vasodilator challenge during echocardiography, by tracking the changes of echo parameters (such as RVSP) before and after iloprost challenge, as well as through the 3 and 12 month follow-up visits.
- Association of change in pressures after vasodilator challenge with clinical outcomes [ Time Frame: 3 months and 12 months ]Observe the association of the percent change of echocardiographically estimated pressures after iloprost challenge with mid-term clinical outcomes (all cause mortality and all cause mortality +/- hospitalization). These data will be collected at 3 months and at 12 months. Data from all hospitalizations will be collected though we will make special note of those related to pulmonary hypertension.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044314
|Contact: Richard A Krasuski, MD||919-684-2407||richard.krasuskI@duke.edu|
|United States, North Carolina|
|Duke University Health System||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Richard A Krasuski, MD 919-684-2407 firstname.lastname@example.org|
|Contact: Stephanie Newbold, MS 919-613-4728 email@example.com|
|Sub-Investigator: Jordan Awerbach, MD|
|Principal Investigator:||Richard A Krasuski, MD||Duke Health|