Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension
Intervention: Inhaled Iloprost (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Duke University Official(s) and/or principal investigator(s): Neil MacIntyre, MD, Principal Investigator, Affiliation: Duke University
Summary
Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right
ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective
pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice
for this condition. The evidence supporting INO safety and efficacy under these
circumstances is sparse, however, and is largely extrapolated from the use of INO in
neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO
makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized
prostacyclins such as iloprost may be a favorable alternative therapy.
Clinical Details
Official title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percent Change in Oxygen Saturation (SpO2) From BaselinePercent Change in Oxygen Saturation (SpO2) From Baseline Change in Mean Heart Rate From Baseline Change in Mean Heart Rate From Baseline Number of Treatment Failures Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Secondary outcome: Change in Cardiac Output (CO) From BaselineChange in Cardiac Output (CO) From Baseline Change in Mean Venous Oxygen Saturation (SvO2) From Baseline Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Detailed description:
Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5
subjects were enrolled in order to study the effects of continuous delivery over a longer
period of time.
Phase 2 - All remaining subjects received Iloprost as a continuous treatment.
The study was designed for an enrollment of 200 subjects and was ended early.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed
by the attending physician.
2. Indwelling arterial catheter.
3. Signed informed consent
Exclusion Criteria:
1. Clinically unstable circulatory condition requiring epinephrine > 0. 1 mcg/kg/min or
levophed, or already meeting treatment failure criteria (see section 5. 3 below)
2. Known hypersensitivity to prostacyclin compounds
3. Patients receiving sildenafil or bosentan
4. Refusal by the attending physician
Locations and Contacts
Additional Information
Starting date: September 2006
Last updated: August 25, 2014
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