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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699712
First Posted: June 18, 2008
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Momentum Research, Inc.
Information provided by:
Nile Therapeutics
June 10, 2008
June 18, 2008
March 25, 2009
June 2008
December 2008   (Final data collection date for primary outcome measure)
Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ]
Same as current
Complete list of historical versions of study NCT00699712 on ClinicalTrials.gov Archive Site
  • Changes in additional hemodynamic measures [ Time Frame: 8 hours ]
  • Diuresis and natriuresis during and after administration of study drug [ Time Frame: 36 hour ]
  • Safety of CD-NP [ Time Frame: 30 Days ]
Same as current
Not Provided
Not Provided
 
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)
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Decompensated Heart Failure
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
  • Experimental: A
    Open-label regimen of doses 1 and 2 of CDNP
    Intervention: Drug: CD-NP (Chimeric natriuretic peptide)
  • Experimental: B
    Open-label regimen of doses 2 and 3 of CDNP
    Intervention: Drug: CD-NP (Chimeric natriuretic peptide)
  • Experimental: C
    Open-label regimen of doses 3 and 4 of CDNP
    Intervention: Drug: CD-NP (Chimeric natriuretic peptide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT00699712
NIL-CDNP-CT003
Yes
Not Provided
Not Provided
Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics
Nile Therapeutics
Momentum Research, Inc.
Study Director: Hsiao Lieu, MD Nile Therapeutics Inc.
Study Director: Gad Cotter, MD Momentum Research, Inc.
Nile Therapeutics
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP