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

Lantheus Medical Imaging

Status and phase: Completed; Phase 4

Conditions: Pulmonary Heart Disease

Treatments: Drug: Definity

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918866

DMP 115-416

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Low Pulmonary Arterial Pressure

Experimental group

Description:

Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.

Treatment:

Drug: Definity

Elevated Pulmonary Arterial Pressure

Experimental group

Description:

Subjects with a PAP of \> or = to 35 mmHg.

Treatment:

Drug: Definity