Overview
Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Status:
Completed
Completed
Trial end date:
2008-12-01
2008-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failurePhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Nile TherapeuticsCollaborator:
Momentum Research, Inc.
Criteria
Key Inclusion Criteria:- Hospitalization for AHF
- In need of hemodynamic monitoring
Key Exclusion Criteria:
- Administration of intravenous radiographic contrast agent within 7 days prior to
screening or planned IV contrast media administration in the 4 days after screening or
acute contrast-induced nephropathy at the time of screening
- Current or planned treatment with any IV therapies, including diuretics, vasodilators
(including nesiritide), vasopressin antagonists, positive inotropic agents and
vasopressors, or mechanical support
- Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of
screening
- Significant pulmonary disease
- Known valvular heart disease
- Any organ transplant recipient or patient currently listed for transplant or admitted
for any transplantation.
- Major surgery within 30 days of screening
- Other major disability or disease with expected survival less than 6 months.
- Major neurologic event, including cerebrovascular events, in the 60 days prior to
screening
- Clinical diagnosis of acute coronary syndrome within 45 days of screening
- Troponin T ≥ 3 times the upper limit of normal at screening
- Significant arrhythmias
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive
cardiomyopathy
- Liver function abnormality
- Administration of an investigational drug or implantation of investigational device,
or participation in another trial, within 30 days prior to screening