Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO) (PRONTO)
Hypertension, Heart Failure
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Antihypertensive Agent, Calcium Channel Blocker
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
Sites / Locations
- Jackson Hospital
- Centinela Hospital
- Louisiana State University Health Sciences Center
- Louisiana State University Health Sciences Center - Emergency Medicine
- Washington University School of Medicine
- Stony Brook University and Medical Center
- Duke University Medical Center
- University of Cincinnati
- The Cleveland Clinic
- Hopial AP-HP Hotel-Dieu
- Hopital AP-HP La Pitie Sapetriere
- Hopital AP-HP Lariboisiere Urgencies-SMUR
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Clevidipine
Standard of Care IV antihypertensive
Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was infused at an initial rate of 2 mg/h for the first 3 minutes. If blood pressure was not in the target range at 3 minutes, clevidipine was titrated to effect thereafter by doubling the dose every 3 min, per physician discretion and as tolerated by the patient until the desired effect until the SBP target range was attained. Once target range was achieved, the infusion rate could be increased or decreased as needed to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
For patients randomized to standard of care (SOC) IV antihypertensive treatment, a continuous infusion of an intravenous antihypertensive agent represented standard of care. The selection of treatment was at the discretion of the investigator. The infusion was to be administered according to the institution's treatment practice.