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NCT01319045 · ClinicalTrials.gov registry record · NA
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
A NA study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01319045 is a NA study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 5 participants.
The verdict
NCT01319045, a NA study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study 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.
Interventions
- DRUG Iloprost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319045
The ClinicalTrials.gov registry entry for NCT01319045 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Iloprost is the first listed.
NCT01319045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01319045 about?
NCT01319045 is a clinical study titled "Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease". 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 mechanism...
What is the current status of trial NCT01319045?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2011-06. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01319045?
The interventions under investigation include: Iloprost (DRUG).
Who is sponsoring clinical trial NCT01319045?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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