Heart Failure Clinical Trial
Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older and providing
Presentation consistent with AHF as manifest by pulmonary congestion
Dyspnea score (sitting) ≥ 50 mm on a 100 mm visual analog scale
In Stage 1, baseline SBP ≥130 - 160 mmHg (measured immediately prior to initiation of study drug); in Stage 2, baseline SBP ≥ 130 mmHg
Exclusion Criteria:
Administration of an IV or oral antihypertensive agent within the previous 2 hours of randomization (short acting oral or sublingual nitrates are permitted)
Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrome
Known or suspected aortic dissection
Acute myocardial infarction (AMI) within the prior 14 days
Dialysis-dependent renal failure
Requirement for immediate endotracheal intubation
Suspected pregnancy or breast feeding female
Intolerance or allergy to calcium channel blockers
Allergy to soybean oil or lecithin
Known liver failure, cirrhosis or pancreatitis
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
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There are 9 Locations for this study
Montgomery Alabama, 36106, United States
Tucson Arizona, 85719, United States
Saint Louis Missouri, 63110, United States
Brooklyn New York, 11215, United States
Brooklyn New York, 11219, United States
Stony Brook New York, 11794, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45267, United States
Houston Texas, 77030, United States
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