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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: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

This is an intra-subject crossover comparative safety study to evaluate the effect of 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 of SonoVue and one dose of placebo during right heart catheterization. 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.


Condition Intervention Phase
Scheduled to Undergo Right Heart Catheterization
 Drug: SonoVue
Drug: Normal Saline
 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:

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Effects of SonoVue and placebo on pulmonary hemodynamics [ Time Frame: Comparison to baseline to timepoints up to 10 minutes post dose ] [ Designated as safety issue: No ]

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
Placebo Comparator: Placebo Drug: Normal Saline
Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

  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
  • Known allergy to one of the ingredients in the investigational product or to any other contrast agents included 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
  Contacts and Locations
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
Last Updated: December 7, 2012
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
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013