Clinical trial NCT00918866: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Heart Disease
Keywords: Phase 4
DEFINITY®
hemodynamics
pulmonary artery pressure
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

  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

Primary outcomes:
measure: Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
timeFrame: 31-35 minutes minus baseline
Secondary outcomes:
measure: Immunology Panel- Complement 3A (C3A)
timeFrame: Out to 70 minutes
measure: Immunology Panel- Complement 5A(C5A)
timeFrame: Out to 70 minutes
measure: Immunology Panel- Interleuken-6
timeFrame: Out to 70 minutes
measure: Immunology Panel- Tryptase
timeFrame: Out to 70 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Saint Louis Park
country: United States
facility: Methodist Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Cardiovascular Consultants
state: Missouri
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: Lantheus Medical Imaging
name: Veronica Lee, MD
role: STUDY_DIRECTOR
References: