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:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00270361
Eligibility Criteria:
Inclusion Criteria:
* Subjects having had at least two hospital admissions (or equivalent treatment) for acutely decompensated CHF within the last 12 months, with at least one of these admissions in the past 30 days, and having received treatment with intravenous vasoactive agents (such as intravenous inotropes, NATRECOR®, or nitroglycerin)
* able to be enrolled and initiate treatment with study drug within 5 to 30 days of last hospital discharge (or equivalent treatment) of acutely decompensated CHF
* have a baseline NYHA (New York Heart Association) Functional Classification III or IV for at least 2 months prior to randomization
* currently receiving optimal treatment with long term oral medications (e.g., diuretics, ACE inhibitors, and beta blockers, unless beta blockers or ACE inhibitors are documented to be contraindicated or not tolerated)
* willing to receive infusions of NATRECOR®, or possibly other medications, at least as frequently as once per week for 12 weeks.
Exclusion Criteria:
* Subjects having systolic blood pressure consistently less than 90 mm Hg
* having had organ transplantation (heart, liver, lung and kidney) in the past or anticipating organ transplantation during the study
* not able or willing to discontinue intermittent or continuous infusions of inotropes if randomized to a NATRECOR® treatment group
* having had a bi-ventricular pacemaker placed within the past 60 days or an automatic implantable cardiac defibrillator placed within the past 30 days
* requiring chronic dialysis or have an expectation that dialysis will be required during the course of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00270361
Study Brief:
Protocol Section:
NCT00270361