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.
Momentum Research, Inc.
Information provided by:
Nile Therapeutics Identifier:
First received: June 10, 2008
Last updated: March 23, 2009
Last verified: March 2009
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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Open-label regimen of doses 1 and 2 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
Experimental: B
Open-label regimen of doses 2 and 3 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
Experimental: C
Open-label regimen of doses 3 and 4 of CDNP
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses


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

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
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Please refer to this study by its identifier: NCT00699712

Russian Federation
Russian Academy of Medical Sciences
Moscow, Russia, Russian Federation, 121552
Sponsors and Collaborators
Nile Therapeutics
Momentum Research, Inc.
Study Director: Hsiao Lieu, MD Nile Therapeutics Inc.
Study Director: Gad Cotter, MD Momentum Research, Inc.
  More Information

Additional Information:
Responsible Party: Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics Identifier: NCT00699712     History of Changes
Other Study ID Numbers: NIL-CDNP-CT003 
Study First Received: June 10, 2008
Last Updated: March 23, 2009
Health Authority: Israel: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Nile Therapeutics:

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on May 30, 2016