Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)

Inclusion Criteria:

• Age 18 years or older

• Presentation consistent with acute heart failure and pulmonary congestion on physicalexamination as evidenced by rales

• Baseline systolic blood pressure (immediately prior to initiation of study drug) of ≥160 mm Hg

• Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)

• Required IV antihypertensive therapy to lower blood pressure

• Written informed consent

Exclusion Criteria:

• Administration of an agent (IV or oral) for the treatment of elevated BP within theprevious 2 hours of randomization. (Previous short-acting non-IV nitrates, continuouspositive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) werepermitted)

• Chest pain and/or electrocardiogram with ST segment changes consistent with acutecoronary syndrome

• Known or suspected aortic dissection

• Acute myocardial infarction within the prior 14 days

• Dialysis-dependant renal failure

• Requirement for immediate endotracheal intubation

• Positive pregnancy test, known pregnancy or breast feeding female

• Intolerance or allergy to calcium channel blockers

• Allergy to soybean oil or egg lecithin

• Known liver failure, cirrhosis or pancreatitis

• Prior directives against advanced life support

• Participation in other clinical research studies involving the evaluation of otherinvestigational drugs or devices within 30 days of enrollment