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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.
Verified by Nile Therapeutics, June 2008

Sponsors and Collaborators: Nile Therapeutics
Momentum Research Inc.
Information provided by: Nile Therapeutics
ClinicalTrials.gov Identifier: NCT00699712
  Purpose

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


Condition Intervention Phase
Acute Decompensated Heart Failure
Drug: CD-NP (Chimeric natriuretic peptide)
Phase II

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Efficacy Study
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)

Further study details as provided by Nile Therapeutics:

Primary Outcome Measures:
  • Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   30
Study Start Date:   June 2008
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Open-label regimen of doses 1 and 2 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
B: Experimental
Open-label regimen of doses 2 and 3 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
C: Experimental
Open-label regimen of doses 3 and 4 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699712

Contacts
Contact: Nancy Vinh     415-875-7885     nvinh@nilethera.com    
Contact: Jennifer Hodge     415-875-7884     jhodge@nilethera.com    

Locations
Russian Federation, Russia
Russian Academy of Medical Sciences     Recruiting
      Moscow, Russia, Russian Federation, 121552

Sponsors and Collaborators
Nile Therapeutics
Momentum Research Inc.

Investigators
Study Director:     Hsiao Lieu, MD     Nile Therapeutics Inc.    
Study Director:     Gad Cotter, MD     Momentum Research Inc.    
  More Information

Sponsor  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Nile Therapeutics ( Hsiao Lieu, MD / Vice President, Clinical Research )
Study ID Numbers:   NIL-CDNP-CT003
First Received:   June 10, 2008
Last Updated:   June 17, 2008
ClinicalTrials.gov Identifier:   NCT00699712
Health Authority:   Israel: Ministry of Health;   Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Nile Therapeutics:
ADHF  
AHF  
HF  

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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