Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01319045
Status:
TERMINATED
Last Update Posted:
2015-01-26
First Post:
2011-03-18
Brief Title:
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment was too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH or high blood pressure in the lungs is common in patients with congenital heart disease Historically these patients suffered significant morbidity and mortality due to a lack of effective therapies More recently advanced therapies which target the mechanisms underlying the development and progression of PAH have been introduced into clinical care Oral intravenous subcutaneous and inhaled therapies are all available for the treatment of PAH Patients with PAH are first treated with oral agents including sildenafil and bosentan However if these agents fail to achieve the desired effect for the patient intravenous or inhaled therapies may be initiated Combination therapy with multiple agents is common in routine clinical care However the most efficacious therapeutic regimen has yet to be delineated The present study seeks to evaluate the efficacy of one specific regimen iloprost an inhaled prostacyclin derivative used in combination with oral therapy sildenafil andor bosentan Iloprost has been approved by the FDA for use in this patient population Adults with PAH already receiving oral therapy will be invited to participate in this study Iloprost will be added to their current therapeutic regimen for a period of three months with pre- and post-treatment assessments These will include a cardiopulmonary exercise test BNP a blood test six minute walking distance and a quality of life questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None