EUCTR2008-003676-22-DEActive, not recruitingNot Applicable
A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure – A Pilot Study (PRONTO) - PRONTO
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- The Medicines Company
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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