Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure



Status:Archived
Conditions:High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2008
End Date:September 2011

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A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)


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.


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.


We found this trial at
14
sites
New Orleans, Louisiana 70112
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Cincinnati, OH
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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3601 West 13 Mile Road
Royal oak, Michigan 48073
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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Cleveland, Ohio 44109
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Cleveland, OH
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Cleveland, Ohio 44195
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Cleveland, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Inglewood, California 90301
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Inglewood, CA
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Leavenworth, Kansas 66048
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Leavenworth, KS
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Montgomery, Alabama 36106
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Montgomery, AL
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Royal Oak, MI
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Shreveport, LA
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Stony Brook, NY
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