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Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF) (PreCONDITION)

This study is currently recruiting participants.
Study NCT00699712.   Last updated on October 19, 2008.   Information provided by Nile Therapeutics

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Descriptive Information Fields
Brief Title  Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Official Title  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)
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

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Changes in additional hemodynamic measures [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Diuresis and natriuresis during and after administration of study drug [ Time Frame: 36 hour ] [ Designated as safety issue: No ]
Safety of CD-NP [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Condition  Acute Decompensated Heart Failure
Intervention  Drug: CD-NP (Chimeric natriuretic peptide)
MEDLINE PMIDs
Links Sponsor This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  30
Start Date  June 2008
Completion Date December 2008
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Nancy Vinh     415-875-7885     nvinh@nilethera.com    
Contact: Jennifer Hodge     415-875-7884     jhodge@nilethera.com    
Location Countries  Russian Federation
Administrative Information Fields
NCT ID  NCT00699712
Organization ID NIL-CDNP-CT003
Secondary IDs ††
Study Sponsor  Nile Therapeutics
Collaborators †† Momentum Research Inc.
Investigators 
Study Director:     Hsiao Lieu, MD     Nile Therapeutics Inc.    
Study Director:     Gad Cotter, MD     Momentum Research Inc.    
Information Provided By Nile Therapeutics
Verification Date October 2008
First Received Date  June 10, 2008
Last Updated Date October 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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