Phase 4
N=32
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Pulmonary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00918866 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose — -1.9; -1.7 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Definity (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lantheus Medical Imaging
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose |
-1.9; -1.7 | — |
| SECONDARY Immunology Panel- Complement 3A (C3A) |
-45.80; -38.20 | — |
| SECONDARY Immunology Panel- Complement 5A(C5A) |
-0.95; 0.78 | — |
| SECONDARY Immunology Panel- Interleuken-6 |
0.31; 0.15 | — |
| SECONDARY Immunology Panel- Tryptase |
-0.24; -0.01 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00918866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.