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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pulmonary Heart Disease

Intervention / Treatment
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* Drug: Definity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 4, DEFINITY®, hemodynamics, pulmonary artery pressure