Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

General Electric (GE)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Hypertension

Treatments: Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878878

GE-191-004

Details and patient eligibility

About

The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be already scheduled for left and/or right heart catheterization for clinical reasons.
• Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
• Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.

Exclusion criteria

• History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
• Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
• Female subjects who are nursing mothers.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Dextrose

Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

Arm B

Experimental group

Treatment:

Drug: Dextrose

Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)