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:
Collaborator:
Momentum Research, Inc.
Information provided by:
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT00699712
First received: June 10, 2008
Last updated: March 23, 2009
Last verified: March 2009
  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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Russian Federation
Russian Academy of Medical Sciences
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

Additional Information:
No publications provided

Responsible Party: Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics
ClinicalTrials.gov 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:
ADHF
AHF
HF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014