Clinical Trial: Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title:

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 and/or 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 Summary:
Sponsor: University of California, Los Angeles

Current Primary Outcome: Safety and Tolerability [ Time Frame: 3 months ]

Number of Participants with adverse events, specifically mortality and heart failure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: March 18, 2011
Date Started: June 2011
Date Completion:
Last Updated: January 13, 2015
Last Verified: January 2015