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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Antihypertensive Agents; Clevidipine; Diltiazem; Isosorbide; Isosorbide Dinitrate; Nicardipine; Nitroglycerin; Nitroprusside

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