The purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (AHF) patients receiving an intravenous (IV) infusion of clevidipine in comparison to standard of care (SOC) and placebo.
Randomization will occur in two stages. Stage 1 patients will be randomized in a double-blinded manner in a 1:1 ratio to receive either clevidipine or placebo IV infusion. Upon completion of Stage 1, Stage 2 patients will be randomized in an open-label manner in a 1:1 ratio to receive either clevidipine or standard of care (SOC) IV infusion. At the time of randomization, a patient-specific, prespecified systolic blood pressure (SBP) target range will be determined and recorded prior to study drug treatment. Up to 500 patients may be enrolled to achieve a total of 100 Stage 1 and 300 Stage 2 patients with confirmed AHF per protocol. A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor the safety of patients. Adverse events will be assessed for 7 days post-study randomization or hospital discharge, whichever occurred sooner. Serious adverse events (SAEs) were assessed for 30 days following study randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded placebo infusion, an oral antihypertensive agent may be administered. The placebo infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Drug Research and Analysis Corporation/Jackson Hospital
Montgomery, Alabama, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Washington University School of Medicine
St Louis, Missouri, United States
Change in dyspnea VAS score from baseline at 3 hours post-baseline
Time frame: Immediately prior to study drug administration (baseline) to 3 hours post-baseline
Median time to reach target BP within the first 30 minutes
Time frame: Study drug initiation through the first 30 minutes of study drug infusion
Percentage of patients who require rescue therapy (ie, receive any alternative IV antihypertensive drug) within the first 30 minutes
Time frame: Study drug initiation through the first 30 minutes of study drug infusion
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Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Transition to oral antihypertensive medication from SOC IV antihypertensive is per institutional practice.
New York Methodist Hospital
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Stony Brook University and Medical Center
Stony Brook, New York, United States
Duke University Hospital
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States