Heart Failure Clinical Trial
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
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.
Full 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 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 alternative agents and transition to oral therapy if needed is detailed in the study 'ARM' and 'INTERVENTION' sections.
A Data Safety Monitoring Board was utilized periodically throughout the study to monitor the safety of patients. Adverse events were assessed for 7 days post-study randomization or hospital discharge, whichever occured first. Serious adverse events (SAEs) were assessed for 30 days following study randomization. Subjects were contacted by telephone or in person up to 5 days after their 30-day time point to determine if any SAEs occurred following study drug treatment and to follow up on the Heath Economic assessments.
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
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There are 13 Locations for this study
Montgomery Alabama, 36106, United States
Inglewood California, 90301, United States
Baton Rouge Louisiana, 70805, United States
New Orleans Louisiana, 70112, United States
St. Louis Missouri, 63110, United States
Stony Brook New York, 11794, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Paris , 75004, France
Paris , 75013, France
Paris , 75475, France
Berlin , 13353, Germany
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