EUCTR2008-003676-22-DE
Active, not recruiting
Not Applicable
A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure – A Pilot Study (PRONTO) - PRONTO
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- acute heart failure and elevated BP (systolic blood pressure [SBP] =160 mm Hg) requiring parenteral IV antihypertensive therapy
- Sponsor
- The Medicines Company
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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