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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Inhaled Iloprost continuous | Experimental | 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. |
|
| Phase 1: Inhaled Iloprost 3 doses | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Iloprost | Drug | A 20 mcg dose of Iloprost will be given initially. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Readings were taken from the medical record and the data may not have been present at the exact time frames. | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Change in Mean Heart Rate From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Change in Mean Heart Rate From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Number of Treatment Failures | Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
| as long as subject was on drug up to approximately 24 hours |
| Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Output (CO) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Change in Cardiac Output (CO) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil MacIntyre, MD | Duke University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. |
| FG001 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Oxygen Saturation (SpO2) From Baseline | Readings were taken from the medical record and the data may not have been present at the exact time frames. | Phase 2 subjects | Posted | Mean | Standard Deviation | percent change | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil MacIntyre, MD | Duke University Medical Center | 919-681-2720 | neil.macintyre@dm.duke.edu |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues. | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
| Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
| BG001 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 1 subjects | Posted | Mean | Standard Deviation | percent change | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
|
|
|
| Primary | Change in Mean Heart Rate From Baseline | Phase 2 subjects | Posted | Mean | Standard Deviation | percent change | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
|
|
|
| Primary | Change in Mean Heart Rate From Baseline | Phase 1 subjects | Posted | Mean | Standard Deviation | percent change | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
|
|
|
| Secondary | Change in Cardiac Output (CO) From Baseline | Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable. | Posted | Mean | Standard Deviation | percent change | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
|
|
|
| Secondary | Change in Cardiac Output (CO) From Baseline | Phase 1 subjects | Posted | Mean | Standard Deviation | percent change | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
|
|
|
| Primary | Number of Treatment Failures | Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
| Posted | Number | participants | as long as subject was on drug up to approximately 24 hours |
|
|
|
| Primary | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter. | Posted | Mean | Standard Deviation | percent change | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
|
|
|
| Primary | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | Phase 1 subjects | Posted | Mean | Standard Deviation | percent change | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
|
|
|
| Secondary | Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues. | Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable. | Posted | Mean | Standard Deviation | percent change | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours |
|
|
|
| Secondary | Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | Phase 1 subjects | Posted | Mean | Standard Deviation | percent change | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially. | 0 | 5 | 0 | 5 |
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| D002318 |
| Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| combined therapy |
|
| end INO |
|
| Title | Measurements |
|---|---|
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| 18 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| combined therapy |
|
| end INO |
|
| Title | Measurements |
|---|---|
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| 18 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| combined therapy |
|
| end INO |
|
| Title | Measurements |
|---|---|
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| 18 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| combined therapy |
|
| end INO |
|
| Title | Measurements |
|---|---|
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| 18 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| combined therapy |
|
| end INO |
|