MedDataX Logo

Safety of SonoVue on Pulmonary Hemodynamics

NCT ID: NCT01306292

Last Updated: 2016-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulmonary hypertension Right heart Catheterization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SonoVue

Ultrasound contrast agent under development

Group Type EXPERIMENTAL

SonoVue

Intervention Type DRUG

dose of 4.8 mL administered intravenously one time

Placebo

normal saline 0.9% for injection used as the comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SonoVue

dose of 4.8 mL administered intravenously one time

Intervention Type DRUG

Placebo

Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sulfur hexafluoride microbubbles sulfur hexafluoride lipid-type A microspheres Normal Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Luigia Storto, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Holy Name Medical Center

Teaneck, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BR1-133

Identifier Type: -

Identifier Source: org_study_id