Status:
COMPLETED
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 patie...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00803634
Start Date
December 1 2008
End Date
March 1 2012
Last Update
August 29 2014
Active Locations (13)
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1
Jackson Hospital
Montgomery, Alabama, United States, 36106
2
Centinela Hospital
Inglewood, California, United States, 90301
3
Louisiana State University Health Sciences Center
Baton Rouge, Louisiana, United States, 70805
4
Louisiana State University Health Sciences Center - Emergency Medicine
New Orleans, Louisiana, United States, 70112