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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)

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.
 
ClinicalTrials.gov Identifier: NCT00699712
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : March 25, 2009
Sponsor:
Collaborator:
Momentum Research, Inc.
Information provided by:
Nile Therapeutics

Tracking Information
First Submitted Date  ICMJE June 10, 2008
First Posted Date  ICMJE June 18, 2008
Last Update Posted Date March 25, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Decompensated Heart Failure
Intervention  ICMJE Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 17, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699712
Other Study ID Numbers  ICMJE NIL-CDNP-CT003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics
Study Sponsor  ICMJE Nile Therapeutics
Collaborators  ICMJE Momentum Research, Inc.
Investigators  ICMJE
Study Director: Hsiao Lieu, MD Nile Therapeutics Inc.
Study Director: Gad Cotter, MD Momentum Research, Inc.
PRS Account Nile Therapeutics
Verification Date March 2009

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