Safety of SonoVue on Pulmonary Hemodynamics

NCT01306292 | Completed Phase 2 Results

• 1 other identifier: BR1-133
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension; Right heart Catheterization

Outcome Measures

Primary Outcomes (3)

• Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline

  A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) \>=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP \<25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.

  Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)

• Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline

  All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.

  Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)

• Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline

  All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (Qp \[litres per minute\]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: \[(mean PAP-PCWP) divided by Qp\] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.

  Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)

Study Arms (2)

SonoVue

EXPERIMENTAL

Ultrasound contrast agent under development

Drug: SonoVue

Placebo

PLACEBO COMPARATOR

normal saline 0.9% for injection used as the comparator

Drug: Placebo

Interventions

SonoVue DRUG

dose of 4.8 mL administered intravenously one time

Also known as: sulfur hexafluoride microbubbles, sulfur hexafluoride lipid-type A microspheres

SonoVue

Placebo DRUG

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

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

contrast agent BR1; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Maria Luigia Storto
• Organization: Bracco Diagnostics Inc.

marialuigia.storto@diag.bracco.com

609-514-2262

Study Officials

• Maria Luigia Storto, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 1, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 7, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)