A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Primary Purpose
Pulmonary Heart Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Definity
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Heart Disease focused on measuring Phase 4, DEFINITY®, hemodynamics, pulmonary artery pressure
Eligibility 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:
- are not pregnant and have been using an adequate and medically approved method of contraception
- 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
Sites / Locations
- Northwestern Memorial Hospital
- University of Chicago Medical Center
- Methodist Hospital
- Cardiovascular Consultants
- Holy Name Hospital
- The Cleveland Clinic Foundation
- Oregon Health and Sciences University
- The University of Texas Medical Branch at Galveston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Pulmonary Arterial Pressure
Elevated Pulmonary Arterial Pressure
Arm Description
Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
Subjects with a PAP of > or = to 35 mmHg.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Immunology Panel- Complement 3A (C3A)
Evaluate the Immunology Panel after the administration of DEFINITY
Immunology Panel- Complement 5A(C5A)
Evaluate the Immunology Panel after the administration of DEFINITY
Immunology Panel- Interleuken-6
Evaluate the Immunology Panel after the administration of DEFINITY
Immunology Panel- Tryptase
Evaluate the Immunology Panel after the administration of DEFINITY
Full Information
NCT ID
NCT00918866
First Posted
June 4, 2009
Last Updated
November 6, 2020
Sponsor
Lantheus Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00918866
Brief Title
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Heart Disease
Keywords
Phase 4, DEFINITY®, hemodynamics, pulmonary artery pressure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Pulmonary Arterial Pressure
Arm Type
Experimental
Arm Description
Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
Arm Title
Elevated Pulmonary Arterial Pressure
Arm Type
Experimental
Arm Description
Subjects with a PAP of > or = to 35 mmHg.
Intervention Type
Drug
Intervention Name(s)
Definity
Other Intervention Name(s)
Perflutren Lipid Microsphere
Intervention Description
one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight
Primary Outcome Measure Information:
Title
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
Description
Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose
Time Frame
31-35 minutes minus baseline
Secondary Outcome Measure Information:
Title
Immunology Panel- Complement 3A (C3A)
Description
Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame
Out to 70 minutes
Title
Immunology Panel- Complement 5A(C5A)
Description
Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame
Out to 70 minutes
Title
Immunology Panel- Interleuken-6
Description
Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame
Out to 70 minutes
Title
Immunology Panel- Tryptase
Description
Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame
Out to 70 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
are not pregnant and have been using an adequate and medically approved method of contraception
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Lee, MD
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Methodist Hospital
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Cardiovascular Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
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