Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
Condition: Hypertension; Heart Failure
MeSH terms: Hypertension; Heart Failure
Intervention: Clevidipine; Standard of Care IV antihypertensive
Intervention description: Clevidipine was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative IV antihypertensive agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Patients who received an alternative antihypertensive agent along with the study drug were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered approximately 1 hour prior to the termination of clevidipine with study drug down-titrated or terminated in order to maintain the desired blood pressure level.; SOC IV antihypertensive agent will be administered for a minimum of 30 min and, if medically warranted, may continue beyond 96 hours at the investigator's discretion. As with clevidipine, the SOC agent was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Higher dose titration rates were required to be attempted prior to making the decision to switch to or add on an alternative antihypertensive agent(s). Patients who received an alternative antihypertensive agent with SOC were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered per institutional practice.
Intervention MeSH terms: Antihypertensive Agents; Diltiazem; Nitroprusside; Nicardipine; Clevidipine; Isosorbide; Isosorbide Dinitrate; Nitroglycerin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Antihypertensive Agent; Calcium Channel Blocker

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.
    

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