Safety of SonoVue on Pulmonary Hemodynamics

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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

Key facts

Study ID

NCT01306292

Run by

Bracco Diagnostics, Inc

People needed

36

Starts

2011-04-01

Expected to finish

2011-11-01

Last updated by the study team

2016-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Holy Name Medical Center — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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