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Keep this study
Lead
Bracco Diagnostics, Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons
You may not be if
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