Clinical trial NCT02170519: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Official title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percent Change in Oxygen Saturation (SpO2) From Baseline
timeFrame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
measure: Percent Change in Oxygen Saturation (SpO2) From Baseline
timeFrame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
measure: Change in Mean Heart Rate From Baseline
timeFrame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
measure: Change in Mean Heart Rate From Baseline
timeFrame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
measure: Number of Treatment Failures
timeFrame: as long as subject was on drug up to approximately 24 hours
measure: Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
timeFrame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
measure: Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
timeFrame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Secondary outcomes:
measure: Change in Cardiac Output (CO) From Baseline
timeFrame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
measure: Change in Cardiac Output (CO) From Baseline
timeFrame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
measure: Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
timeFrame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
measure: Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
timeFrame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Neil MacIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References: