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Troy, Michigan 48085


Purpose:

The purpose of this study is 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.


Study summary:

This study will be an open-label randomized efficacy and safety pilot trial in patients with acute heart failure and hypertension (SBP ≥160 mm Hg) requiring parenteral antihypertensive therapy. The study will include 3 separate periods: Screening Period, Treatment Period (up to 96 h) and Follow-up Period (up to 30 days post-randomization) representing approximately a maximum of 30 days on study. Eligible patients will be randomized to receive clevidipine or SOC IV antihypertensive treatment (study drug) in an open-label manner in a ratio of 1:1. At the time of randomization, a prespecified target SBP range will be recorded. Clevidipine will be infused at an initial rate of 2 mg/h for the first 3 min. Thereafter, titration to higher infusion rates can be attempted as needed to obtain the prespecified target SBP range. Titration to effect is to proceed by doubling the dose every 3 min, up to a maximum of 32 mg/h, until the desired effect (SBP within the prespecified target range) is attained. SOC IV antihypertensive treatment will be administered per the institution's treatment practice. During the initial 30 min of the treatment period, clevidipine or SOC IV antihypertensive treatment should be administered as monotherapy until 30 min post-initiation of study drug. The use of an alternative antihypertensive agent(s) or changing the SBP target range is discouraged and limited to where medically necessary to maintain patient safety. Clevidipine may continue for a maximum of 96 hours. If medically warranted, SOC IV antihypertensive treatment may continue beyond 96 hours at the investigator's discretion. A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor the safety of patients. AEs will continue to be assessed for 7 days or discharge whichever occurs first following randomization. SAEs will be assessed for 30 days following randomization. Subjects will be contacted by telephone or in person to determine if any SAEs have occurred following study drug treatment and to follow up on Heath Economic assessments. Up to 5 additional days will be allowed to complete this final assessment.


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 (before starting study drug) of ≥160 mm Hg - Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale - Requires IV antihypertensive therapy to lower BP - 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, and bi-level positive airway pressure are 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


NCT ID:

NCT00803634


Primary Contact:

Principal Investigator
W. Frank Peacock, MD
The Cleveland Clinic


Backup Contact:

N/A


Location Contact:

Troy, Michigan 48085
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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