Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Jamil Aboulhosn, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE March 18, 2011
First Posted Date  ICMJE March 21, 2011
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE December 29, 2014
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
Safety and Tolerability [ Time Frame: 3 months ]
Number of Participants with adverse events, specifically mortality and heart failure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
Official Title  ICMJE Not Provided
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Congenital Heart Disease
  • Eisenmenger's Syndrome
Intervention  ICMJE Drug: Iloprost
Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Other Name: Ventavis, prostacyclin analogue
Study Arms  ICMJE Experimental: Iloprost
Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Intervention: Drug: Iloprost
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2011)
16
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than or equal to 18 years old
  • Congenital heart disease with pulmonary arterial hypertension and cyanosis (resting oxygen saturation < 90% on room air)
  • Stable on oral therapy (PDE5 inhibitor and/or endothelin blockade) for at least three months

Exclusion Criteria:

  • Age < 18 years old
  • Current intravenous or subcutaneous prostacyclin therapy
  • Resting Systemic Hypotension (Systolic blood pressure < 85 mmHg)
  • Women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers
  • Inability to ambulate
  • Planned surgical procedure during the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01319045
Other Study ID Numbers  ICMJE Iloprost ACHD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamil Aboulhosn, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Actelion
Investigators  ICMJE
Principal Investigator: Jamil A Aboulhosn, MD Ahmanson / UCLA Adult Congenital Heart Disease Center
PRS Account University of California, Los Angeles
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP