A Phase 2 interventional study of SonoVue and Placebo in Pulmonary Hypertension, sponsored by Bracco Diagnostics, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by Bracco Diagnostics, Inc · Phase 2 and Interventional
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 36 is close to the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Bracco Diagnostics, Inc is the lead sponsor of 48 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound contrast agent under development
Drug: SonoVue
normal saline 0.9% for injection used as the comparator
Drug: Placebo
dose of 4.8 mL administered intravenously one time
Also known as: sulfur hexafluoride microbubbles, sulfur hexafluoride lipid-type A microspheres
Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)
Also known as: Normal Saline
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.
Time frame: 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.
Time frame: 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.
Time frame: Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)
| Milestone | Hypertension Group (SonoVue First, Then Placebo) | Hypertension Group (Placebo First, Then SonoVue) | Normal Group (SonoVue First, Then Placebo) | Normal Group (Placebo First, Then SonoVue) |
|---|---|---|---|---|
| Started | 10 | 8 | 8 | 10 |
| Completed | 10 | 8 | 8 | 10 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Hypertension Group (SonoVue First, Then Placebo) | Hypertension Group (Placebo First, Then SonoVue) | Normal Group (SonoVue First, Then Placebo) | Normal Group (Placebo First, Then SonoVue) |
|---|---|---|---|---|
| Started | 10 | 8 | 8 | 10 |
| Completed | 10 | 8 | 8 | 10 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Hypertension Group (SonoVue First, Then Placebo) | Hypertension Group (Placebo First, Then SonoVue) | Normal Group (SonoVue First, Then Placebo) | Normal Group (Placebo First, Then SonoVue) |
|---|---|---|---|---|
| Started | 10 | 8 | 8 | 10 |
| Completed | 10 | 8 | 7 | 10 |
| Not completed | 0 | 0 | 1 | 0 |
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.
| mmHg | Hypertension Placebo | Hypertension SonoVue | Normal Placebo | Normal SonoVue |
|---|---|---|---|---|
| Baseline Systolic PAP (mmHg) | 50.50 ± 17.581 | 50.50 ± 17.581 | 30.08 ± 6.001 | 30.08 ± 6.001 |
| 1 minute post-dose | -2.17 ± 5.993 | -3.33 ± 5.407 | 1.31 ± 3.214 | 0.47 ± 2.464 |
| 4 minutes post-dose | -3.06 ± 5.196 | -2.94 ± 5.352 | 1.50 ± 4.345 | 0.62 ± 2.485 |
| 7 minutes post-dose | -1.94 ± 6.010 | -2.28 ± 4.854 | 0.86 ± 3.940 | -0.32 ± 2.215 |
| 10 minutes post-dose | -2.44 ± 6.849 | -2.17 ± 5.300 | 0.03 ± 4.816 | -0.69 ± 3.945 |
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.
| mmHg | Hypertension Placebo | Hypertension SonoVue | Normal Placebo | Normal SonoVue |
|---|---|---|---|---|
| Baseline Diastolic PAP (mmHg) | 24.11 ± 7.177 | 24.11 ± 7.177 | 11.72 ± 3.750 | 11.72 ± 3.750 |
| 1 minute post-dose | -3.39 ± 4.661 | -1.50 ± 3.884 | 1.44 ± 3.481 | 1.22 ± 4.156 |
| 4 minutes post-dose | -3.56 ± 4.362 | -2.78 ± 6.839 | 0.44 ± 3.508 | 0.68 ± 2.767 |
| 7 minutes post-dose | -3.22 ± 5.342 | -3.06 ± 4.325 | 1.61 ± 2.471 | 1.09 ± 3.104 |
| 10 minutes post-dose | -3.44 ± 5.731 | -1.83 ± 4.836 | 1.39 ± 2.207 | 0.78 ± 3.723 |
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.
| dyne*sec/cm^5 | Hypertension Placebo | Hypertension SonoVue | Normal Placebo | Normal SonoVue |
|---|---|---|---|---|
| Baseline PVR (dyne*sec/cm^5) | 307.189 ± 307.6268 | 307.189 ± 307.6268 | 142.714 ± 93.6055 | 142.714 ± 93.6055 |
| 1 minute post-dose | -73.087 ± 186.9939 | -63.065 ± 158.7097 | 20.541 ± 63.4305 | 1.021 ± 55.5296 |
| 10 minutes post-dose | -41.468 ± 226.7863 | -10.028 ± 175.0397 | 21.208 ± 82.9967 | -6.117 ± 52.0617 |
Collected over Adverse events were to be monitored from the time of signed informed consent until 24 hours after the last investigational product administration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypertension Group | — | 0/18 (0%) | 1/18 (5.6%) |
| Normal Pulmonary Pressure Group | — | 0/18 (0%) | 2/18 (11.1%) |
| Event | Hypertension Group | Normal Pulmonary Pressure Group |
|---|---|---|
| Catheter site painGeneral disorders | 1/18 | 0/18 |
| ChillsGeneral disorders | 0/18 | 1/18 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/18 | 1/18 |
| Age, Categorical(Participants) | Hypertension Group | Normal Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 6 | 4 | 10 |
| Age, Continuous(years) | Hypertension Group | Normal Group | Total |
|---|---|---|---|
| Mean | 58.0 ± 12.96 | 57.2 ± 10.70 | 57.6 ± 11.72 |
| Gender(Participants) | Hypertension Group | Normal Group | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 13 | 12 | 25 |
| Region of Enrollment(participants) | Hypertension Group | Normal Group | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
Plan to share: Yes — Study of Lumason pulmonary hemodynamics
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Bracco Diagnostics, Inc