Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00803634
Eligibility 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 (immediately prior to initiation of study drug) of ≥160 mm Hg
* Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)
* Required IV antihypertensive therapy to lower blood pressure
* 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 (CPAP), and bi-level positive airway pressure (BiPAP) were 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00803634
Study Brief:
Protocol Section:
NCT00803634