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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low Pulmonary Arterial Pressure	Definity	Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.
Elevated Pulmonary Arterial Pressure	Definity	Subjects with a PAP of \> or = to 35 mmHg.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (8): Cardiovascular Consultants
🇺🇸
Kansas City, Missouri, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Methodist Hospital
🇺🇸
Saint Louis Park, Minnesota, United States
Oregon Health and Sciences University
🇺🇸
Portland, Oregon, United States
The University of Texas Medical Branch at Galveston
🇺🇸
Galveston, Texas, United States
Holy Name Hospital
🇺🇸
Teaneck, New Jersey, United States