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

Launched by THE MEDICINES COMPANY · Dec 4, 2008

Keywords

ClinConnect Summary

This study was an open-label randomized efficacy and safety pilot trial in patients with acute heart failure (AHF) and hypertension (systolic blood pressure \[SBP\] ≥160 mm Hg) requiring parenteral antihypertensive therapy. Eligible patients were randomized to receive clevidipine or standard of care (SOC) intravenous antihypertensive treatment in an open-label manner in a ratio of 1:1. At the time of randomization, a patient-specific, prespecified SBP target range was determined and be recorded, prior to study drug treatment. Information on the dosing regimen, use of additional or alternati...

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Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Presentation consistent with acute heart failure and pulmonary congestion on physical examination 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 the previous 2 hours of randomization. (Previous short-acting non-IV nitrates, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) were permitted)
• • Chest pain and/or electrocardiogram with ST segment changes consistent with acute coronary 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 other investigational drugs or devices within 30 days of enrollment