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Trial record 4 of 4 for:    8532025 [PUBMED-IDS]

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
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Jamil Aboulhosn, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Congenital Heart Disease Eisenmenger's Syndrome Drug: Iloprost Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


Arm Intervention/treatment
Experimental: Iloprost
Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Drug: Iloprost
Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Other Name: Ventavis, prostacyclin analogue




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 3 months ]
    Number of Participants with adverse events, specifically mortality and heart failure.


Secondary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 3 months ]
    Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.

  2. Serum Brain Natriuretic Peptide (BNP) [ Time Frame: 3 months ]
    Change in serum BNP level

  3. Quality of Life [ Time Frame: 3 months ]
    Change in quality of life as assessed by SF-36 QOL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Actelion
Investigators
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Principal Investigator: Jamil A Aboulhosn, MD Ahmanson / UCLA Adult Congenital Heart Disease Center

Publications:

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Responsible Party: Jamil Aboulhosn, Assistant Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01319045     History of Changes
Other Study ID Numbers: Iloprost ACHD
First Posted: March 21, 2011    Key Record Dates
Results First Posted: December 29, 2014
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Jamil Aboulhosn, University of California, Los Angeles:
Pulmonary Arterial Hypertension
Congenital Heart Disease
Eisenmenger's Syndrome
Prostacyclin
Iloprost
Additional relevant MeSH terms:
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Hypertension
Heart Diseases
Heart Defects, Congenital
Eisenmenger Complex
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Epoprostenol
Iloprost
Tezosentan
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents