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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Lantheus Medical Imaging

Current Primary Outcome: 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 ]

Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose


Original Primary Outcome: Primary outcome is the evaluation of the effect of DEFINITY® on Pulmonary Artery Hemodynamics. [ Time Frame: 3-4 months ]

Current Secondary Outcome:

  • Immunology Panel- Complement 3A (C3A) [ Time Frame: Out to 70 minutes ]
    Evaluate the Immunology Panel after the administration of DEFINITY
  • Immunology Panel- Complement 5A(C5A) [ Time Frame: Out to 70 minutes ]
    Evaluate the Immunology Panel after the administration of DEFINITY
  • Immunology Panel- Interleuken-6 [ Time Frame: Out to 70 minutes ]
    Evaluate the Immunology Panel after the administration of DEFINITY
  • Immunology Panel- Tryptase [ Time Frame: Out to 70 minutes ]
    Evaluate the Immunology Panel after the administration of DEFINITY


Original Secondary Outcome:

Information By: Lantheus Medical Imaging

Dates:
Date Received: June 4, 2009
Date Started: July 2009
Date Completion:
Last Updated: March 30, 2015
Last Verified: October 2011