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Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

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ClinicalTrials.gov Identifier: NCT02170519
Recruitment Status : Terminated (Project was completed)
First Posted : June 23, 2014
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Inhaled Iloprost Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Study Start Date : September 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 2: Inhaled Iloprost continuous

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.

Drug: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
Other Name: Ventavis

Experimental: Phase 1: Inhaled Iloprost 3 doses

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.

Drug: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
Other Name: Ventavis




Primary Outcome Measures :
  1. Percent Change in Oxygen Saturation (SpO2) From Baseline [ Time Frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours ]
    Readings were taken from the medical record and the data may not have been present at the exact time frames.

  2. Percent Change in Oxygen Saturation (SpO2) From Baseline [ Time Frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) ]
  3. Change in Mean Heart Rate From Baseline [ Time Frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours ]
  4. Change in Mean Heart Rate From Baseline [ Time Frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) ]
  5. Number of Treatment Failures [ Time Frame: as long as subject was on drug up to approximately 24 hours ]

    Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:

    1. Cardiac Index (CI) >/= 1.8 L/min/m2
    2. Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine
    3. MAP </= 50 mmHg (or as appropriate for age in pediatrics).
    4. SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}

  6. Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline [ Time Frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours ]
  7. Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline [ Time Frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) ]

Secondary Outcome Measures :
  1. Change in Cardiac Output (CO) From Baseline [ Time Frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours ]
  2. Change in Cardiac Output (CO) From Baseline [ Time Frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) ]
  3. Change in Mean Venous Oxygen Saturation (SvO2) From Baseline [ Time Frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours ]
    SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.

  4. Change in Mean Venous Oxygen Saturation (SvO2) From Baseline [ Time Frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02170519


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Neil MacIntyre, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02170519    
Other Study ID Numbers: Pro00013737
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014
Last Verified: June 2014
Keywords provided by Duke University:
pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Lung Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents