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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00918866
First received: June 4, 2009
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Heart Disease
Drug: Definity
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose [ Time Frame: 31-35 minutes minus baseline ] [ Designated as safety issue: Yes ]
    Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose


Secondary Outcome Measures:
  • Immunology Panel- Complement 3A (C3A) [ Time Frame: Out to 70 minutes ] [ Designated as safety issue: Yes ]
    Evaluate the Immunology Panel after the administration of DEFINITY

  • Immunology Panel- Complement 5A(C5A) [ Time Frame: Out to 70 minutes ] [ Designated as safety issue: Yes ]
    Evaluate the Immunology Panel after the administration of DEFINITY

  • Immunology Panel- Interleuken-6 [ Time Frame: Out to 70 minutes ] [ Designated as safety issue: Yes ]
    Evaluate the Immunology Panel after the administration of DEFINITY

  • Immunology Panel- Tryptase [ Time Frame: Out to 70 minutes ] [ Designated as safety issue: Yes ]
    Evaluate the Immunology Panel after the administration of DEFINITY


Enrollment: 32
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Perflutren Lipid Microsphere

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918866

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Minnesota
Methodist Hospital
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111
United States, New Jersey
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Texas
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Veronica Lee, MD Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00918866     History of Changes
Other Study ID Numbers: DMP 115-416
Study First Received: June 4, 2009
Results First Received: December 17, 2010
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Phase 4
DEFINITY®
hemodynamics
pulmonary artery pressure

Additional relevant MeSH terms:
Heart Diseases
Pulmonary Heart Disease
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014