Safety of SonoVue on Pulmonary Hemodynamics
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2011 |
End Date: | November 2011 |
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
This is an intra-subject crossover comparative safety study to evaluate the effect of
intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.
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.
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.
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
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