Safety of SonoVue on Pulmonary Hemodynamics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01306292
First received: February 23, 2011
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

Condition Intervention Phase
Pulmonary Hypertension
Drug: SonoVue
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Crossover, Safety Study of the Effect of Intravenous Bolus Injections of SonoVue on Pulmonary Hemodynamics in Subjects With and Without Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline [ Time Frame: Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) ] [ Designated as safety issue: No ]
    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.

  • Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline [ Time Frame: Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose) ] [ Designated as safety issue: No ]
    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.

  • Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline [ Time Frame: Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose) ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SonoVue
Ultrasound contrast agent under development
Drug: SonoVue
dose of 4.8 mL administered intravenously one time
Other Names:
  • sulfur hexafluoride microbubbles
  • sulfur hexafluoride lipid-type A microspheres
Placebo Comparator: Placebo
normal saline 0.9% for injection used as the comparator
Drug: Placebo
Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)
Other Name: Normal Saline

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons

Exclusion Criteria:

  • Pregnant or lactating females
  • Significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics by catheterization
  • Known allergy to one of the ingredients in the investigational product or to any other contrast agents including ultrasound contrast agents
  • Previously entered into the study or received an investigational compound within 30 days before admission into the study
  • Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect of the investigational products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306292

Locations
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01306292     History of Changes
Other Study ID Numbers: BR1-133 
Study First Received: February 23, 2011
Results First Received: February 10, 2015
Last Updated: January 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Bracco Diagnostics, Inc:
Pulmonary hypertension
Right heart Catheterization

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2016