A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure

A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure

The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.

Study Overview

• Status: Completed
• Conditions: Pulmonary Heart Disease
• Intervention / Treatment: Drug: Definity

Detailed Description

This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.

The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Methodist Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Cardiovascular Consultants
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
  • Texas
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch at Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
• Be male or female above the age of 18
• Female patients who no longer have child-bearing potential

• Women of Child-Bearing Potential(WOCBP) who:

  1. are not pregnant and have been using an adequate and medically approved method of contraception
  2. have a negative urine pregnancy test
• Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

• Women who are pregnant or lactating
• Known hypersensitivity or contraindication to or greater heart block
• Previous heart transplant
• Known right-to-left shunt (including atrial septal defect)
• Severe pulmonary artery hypertension (i.e., > 75 mmHg
• Current uncontrolled ventricular tachycardia
• Second-degree or greater heart block
• Any contraindications for the use of a right heart catheter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Pulmonary Arterial Pressure; Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Drug: Definity; one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight; Other Names: Perflutren Lipid Microsphere
Experimental: Elevated Pulmonary Arterial Pressure; Subjects with a PAP of > or = to 35 mmHg.	Drug: Definity; one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight; Other Names: Perflutren Lipid Microsphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose	Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose	31-35 minutes minus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunology Panel- Complement 3A (C3A)	Evaluate the Immunology Panel after the administration of DEFINITY	Out to 70 minutes
Immunology Panel- Complement 5A(C5A)	Evaluate the Immunology Panel after the administration of DEFINITY	Out to 70 minutes
Immunology Panel- Interleuken-6	Evaluate the Immunology Panel after the administration of DEFINITY	Out to 70 minutes
Immunology Panel- Tryptase	Evaluate the Immunology Panel after the administration of DEFINITY	Out to 70 minutes

Collaborators and Investigators

• Sponsor: Lantheus Medical Imaging

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: hemodynamics; Phase 4; pulmonary artery pressure; DEFINITY®
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: DMP 115-416