Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT01319045|
Recruitment Status : Terminated (enrollment was too slow)
First Posted : March 21, 2011
Results First Posted : December 29, 2014
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Congenital Heart Disease Eisenmenger's Syndrome||Drug: Iloprost||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Other Name: Ventavis, prostacyclin analogue
- Safety and Tolerability [ Time Frame: 3 months ]Number of Participants with adverse events, specifically mortality and heart failure.
- Exercise Capacity [ Time Frame: 3 months ]Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.
- Serum Brain Natriuretic Peptide (BNP) [ Time Frame: 3 months ]Change in serum BNP level
- Quality of Life [ Time Frame: 3 months ]Change in quality of life as assessed by SF-36 QOL
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): NCT01319045
|United States, California|
|Ronald Reagan UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Jamil A Aboulhosn, MD||Ahmanson / UCLA Adult Congenital Heart Disease Center|