Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension Right heart Catheterization
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: no

Brief summary:
This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

Detailed description:
Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by SonoVue. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.

Arms:
arm 1: Ultrasound contrast agent under development arm 2: normal saline 0.9% for injection used as the comparator

Interventions: intervention 1: SonoVue intervention 2: Placebo
Intervention descriptions: intervention 1: dose of 4.8 mL administered intravenously one time intervention 2: Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

Protocol document: