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

• Conditions: acute heart failure and elevated BP (systolic blood pressure [SBP] =160 mm Hg) requiring parenteral IV antihypertensive therapy; MedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failure; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2008-003676-22-DE
• Lead Sponsor: The Medicines Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-09
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age 18 years or older
2. Presentation consistent with AHF and pulmonary congestion on physical examination as evidenced by rales.
3. Baseline SBP (immediately prior to initiation of study drug) of =160 mm Hg
4. Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)
5. Requires IV antihypertensive therapy to lower BP
6. Written informed consent before initiation of any study related procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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, CPAP and BiPAP are permitted)
2. Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrom.
3. Known or suspected aortic dissection
4. Acute Myocardial Infarction (AMI) within the prior 14 days
5. Dialysis dependant renal failure
6. Requirement for immediate endotracheal intubation
7. Positive pregnancy test, known pregnancy or breast feeding female
8. Intolerance or allergy to calcium channel blockers
9. Allergy to soybean oil or egg lecithin
10. Known liver failure, cirrhosis or pancreatitis
11. Prior directives against advanced life support (no code status)
12. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of an intravenous (IV) infusion of clevidipine as compared with standard of care (SOC) IV antihypertensive for blood pressure (BP) lowering in patients with acute heart failure (AHF) and elevated BP. ;Secondary Objective: Exploratory objectives are to evaluate the effects on fluid balance, diuretic use and renal function and the evaluation of health economic parameters and resource utilization with clevidipine as compared to SOC IV antihypertensive treatment. ;Primary end point(s): Median time and percent of patients that attain the initial prespecified systolic blood pressure (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