Clinical trial NCT01306292: Safety of SonoVue on Pulmonary Hemodynamics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension
Right heart Catheterization
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline
timeFrame: Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)
measure: Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline
timeFrame: Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)
measure: Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline
timeFrame: Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Maria Luigia Storto, MD
role: STUDY_DIRECTOR
References: