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Baton Rouge, Louisiana 70805

  • Heart Failure

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


Study is Available At:


Original ID:

TMC-CLV-08-01


NCT ID:

NCT00803634


Secondary ID:


Study Acronym:

PRONTO


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Medicines Company


Oversight Authority:

  • United States: Food and Drug Administration
  • France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
  • Germany: Federal Institute for Drugs and Medical Devices
  • Switzerland: Swissmedic


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

117


Enrollment Type:

Actual


Overall Contact Information

Official Name:W. Frank Peacock, MD
Principal Investigator
The Cleveland Clinic

Study Dates

Start Date:December 2008
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 6, 2012
First Received Date:December 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Median time and percent of patients that attain the initial prespecified SBP target range (minimum of 20 mm Hg and a maximum of 40 mm Hg apart) and a 15% reduction in SBP from baseline within the first 30 minutes
Time Frame:Within initial 30-minute treatment period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The percentage of patients who reach the prespecified SBP target range without falling below the lower limit of the prespecified target range during the first 30 minute treatment period
Time Frame:First 30-minute treatment period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Magnitude and duration of SBP excursions (calculated as area under the curve) outside the target range(s) normalized per hour for the duration of the study drug administration up to 96 hours
Time Frame:Duration of study drug administration up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The percentage of patients in whom the SBP falls below the lower limit of the prespecified target range at any time during the first 30 minutes and below the target range at any time during the entire study drug treatment period up to 96 hours
Time Frame:Study drug treatment period, up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in the dyspnea scores (Visual Analogue Score, Vasodilatation in the Management of Acute Congestive Heart Failure, and Provocative Dyspnea Assessment) at each time point
Time Frame:Up to 1 hour post-termination of study drug treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Length of time on study drug without using any other concomitant IV antihypertensive agent up to 96 hours
Time Frame:Up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients who receive any alternative IV antihypertensive drug at any time during the study drug treatment period up to 96 hours
Time Frame:Up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of episodes and percent time the SBP < 90 mm Hg during study drug administration up to 96 hours
Time Frame:Up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of patients that require intubation during study drug administration up to 96 hours
Time Frame:Up to 96 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety of a prolonged infusion of study drug assessed according to clinical laboratory parameters, and adverse events and SAEs up to 7 days or discharge whichever occurs first and SAEs through 30 days from randomization into the study
Time Frame:AEs will be assessed up to 7 days or discharge, whichever occurs first following randomization. SAEs
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Clevidipine butyrate injectable emulsion
Description:Clevidipine (0.5 mg/mL in 20% lipid emulsion; 100 mL bottles) will be administered intravenously via a single dedicated line to all patients randomized to receive clevidipine. Clevidipine will be infused at an initial rate of 2 mg/h for the first 3 min. Thereafter, 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 target range) is attained. Clevidipine will be administered for a minimum of 30 min and a maximum
Arm Name:Clevidipine butyrate injectable emulsion
Other Name:Cleviprex
Intervention Type:Drug
Name:standard of care IV antihypertensive treatment
Description:For patients randomized to standard of care (SOC) IV antihypertensive treatment, the selection of treatment is at the discretion of the investigator. Infusion must be administered per the institution's treatment practice and dose titration performed to a maximum allowed or tolerated dose to achieve SBP control. 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.
Arm Name:standard of care IV antihypertensive treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Clevidipine butyrate injectable emulsion
Study Arm Type:Active Comparator
Arm Name:standard of care IV antihypertensive treatment

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The Medicines Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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