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

Completed · Phase 3

Conditions studied: Hypertension, Heart Failure

In brief

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.

Key facts

Study ID

NCT00803634

Run by

The Medicines Company

People needed

117

Starts

2008-12-01

Expected to finish

2012-03-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jackson Hospital — Montgomery, Alabama, United States
• Centinela Hospital — Inglewood, California, United States
• Louisiana State University Health Sciences Center — Baton Rouge, Louisiana, United States
• Louisiana State University Health Sciences Center - Emergency Medicine — New Orleans, Louisiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Stony Brook University and Medical Center — Stony Brook, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Hopial AP-HP Hotel-Dieu — Paris, France
• Hopital AP-HP La Pitie Sapetriere — Paris, France
• Hopital AP-HP Lariboisiere Urgencies-SMUR — Paris, France
• Charité - Universitätsmedizin Berlin — Berlin, Germany

Full record on ClinicalTrials.gov

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