Safety of SonoVue on Pulmonary Hemodynamics

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

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