Title

Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    30
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
Study Started
Jun 30
2008
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Mar 25
2009
Estimate

Drug CD-NP (Chimeric natriuretic peptide)

Infusion of CDNP at two of four doses

A Experimental

Open-label regimen of doses 1 and 2 of CDNP

B Experimental

Open-label regimen of doses 2 and 3 of CDNP

C Experimental

Open-label regimen of doses 3 and 4 of CDNP

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
No Results Posted