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This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.
Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by SonoVue. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SonoVue | Experimental | Ultrasound contrast agent under development |
|
| Placebo | Placebo Comparator | normal saline 0.9% for injection used as the comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonoVue | Drug | dose of 4.8 mL administered intravenously one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline | A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products. | Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) |
| Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline | All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products. | Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) |
| Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline | All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Luigia Storto, MD | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
Study of Lumason pulmonary hemodynamics
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertension Group (SonoVue First, Then Placebo) | Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes. |
| FG001 | Hypertension Group (Placebo First, Then SonoVue) | Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes. |
| FG002 | Normal Group (SonoVue First, Then Placebo) | Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes. |
| FG003 | Normal Group (Placebo First, Then SonoVue) | Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Injection |
| |||||||||||||
| Washout (at Least 10 Minutes) |
| |||||||||||||
| Second Injection |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertension Group | Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. |
| BG001 | Normal Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline | A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products. | 36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group). | Posted | Mean | Standard Deviation | mmHg | Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) |
Adverse events were to be monitored from the time of signed informed consent until 24 hours after the last investigational product administration.
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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 | Hypertension Group | Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Luigia Storto | Bracco Diagnostics Inc. | 609-514-2262 | marialuigia.storto@diag.bracco.com |
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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 |
|---|---|
| C420843 | contrast agent BR1 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue) |
|
|
| Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline | All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products. | 36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group). | Posted | Mean | Standard Deviation | mmHg | Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) |
|
|
|
| Primary | Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline | All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated. | 36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group). | Posted | Mean | Standard Deviation | dyne*sec/cm^5 | Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose) |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Normal Pulmonary Pressure Group | Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue. | 0 | 18 | 2 | 18 |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| 1 minute post-dose |
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| 4 minutes post-dose |
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| 7 minutes post-dose |
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| 10 minutes post-dose |
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| 1 minute post-dose |
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| 10 minutes post-dose |
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