Status:
COMPLETED
Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Lead Sponsor:
Nile Therapeutics
Collaborating Sponsors:
Momentum Research, Inc.
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 failure
Eligibility Criteria
Inclusion
- Key
- Hospitalization for AHF
- In need of hemodynamic monitoring
- Key
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00699712
Start Date
June 1 2008
End Date
December 1 2008
Last Update
March 25 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Russian Academy of Medical Sciences
Moscow, Russia, Russia, 121552