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

This study will be an open-label randomized efficacy and safety pilot trial in patients with
acute heart failure and hypertension (SBP ≥160 mm Hg) requiring parenteral antihypertensive
therapy. The study will include 3 separate periods: Screening Period, Treatment Period (up
to 96 h) and Follow-up Period (up to 30 days post-randomization) representing approximately
a maximum of 30 days on study.

Eligible patients will be randomized to receive clevidipine or SOC IV antihypertensive
treatment (study drug) in an open-label manner in a ratio of 1:1. At the time of
randomization, a prespecified target SBP range will be recorded. Clevidipine will be infused
at an initial rate of 2 mg/h for the first 3 min. Thereafter, titration to higher infusion
rates can be attempted as needed to obtain the prespecified target SBP range. Titration to
effect is to proceed by doubling the dose every 3 min, up to a maximum of 32 mg/h, until the
desired effect (SBP within the prespecified target range) is attained. SOC IV
antihypertensive treatment will be administered per the institution's treatment practice.

During the initial 30 min of the treatment period, clevidipine or SOC IV antihypertensive
treatment should be administered as monotherapy until 30 min post-initiation of study drug.
The use of an alternative antihypertensive agent(s) or changing the SBP target range is
discouraged and limited to where medically necessary to maintain patient safety. Clevidipine
may continue for a maximum of 96 hours. If medically warranted, SOC IV antihypertensive
treatment may continue beyond 96 hours at the investigator's discretion.

A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor
the safety of patients. AEs will continue to be assessed for 7 days or discharge whichever
occurs first following randomization. SAEs will be assessed for 30 days following
randomization. Subjects will be contacted by telephone or in person to determine if any SAEs
have occurred following study drug treatment and to follow up on Heath Economic assessments.
Up to 5 additional days will be allowed to complete this final assessment.