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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Arterial Hypertension
Congenital Heart Disease
Eisenmenger's Syndrome
Intervention Drug: Iloprost
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iloprost
Hide Arm/Group Description

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Period Title: Overall Study
Started 5
Completed 3 [1]
Not Completed 2
[1]
Study was discontinued due to low enrollment
Arm/Group Title Iloprost
Hide Arm/Group Description

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of Participants with adverse events, specifically mortality and heart failure.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of adverse events.
Arm/Group Title Iloprost
Hide Arm/Group Description:

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Exercise Capacity
Hide Description Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained
Arm/Group Title Iloprost
Hide Arm/Group Description:

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Serum Brain Natriuretic Peptide (BNP)
Hide Description Change in serum BNP level
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained
Arm/Group Title Iloprost
Hide Arm/Group Description:

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Quality of Life
Hide Description Change in quality of life as assessed by SF-36 QOL
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained
Arm/Group Title Iloprost
Hide Arm/Group Description:

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iloprost
Hide Arm/Group Description

Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.

Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

All-Cause Mortality
Iloprost
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Iloprost
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iloprost
Affected / at Risk (%)
Total   0/3 (0.00%) 
Enrollment was too slow. The trial was discontinued.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jamil Aboulhosn
Organization: UCLA
Phone: 310-825-5950
EMail: jaboulhosn@mednet.ucla.edu
Publications:
Layout table for additonal information
Responsible Party: Jamil Aboulhosn, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01319045    
Other Study ID Numbers: Iloprost ACHD
First Submitted: March 18, 2011
First Posted: March 21, 2011
Results First Submitted: December 3, 2014
Results First Posted: December 29, 2014
Last Update Posted: January 26, 2015