Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF) (PreCONDITION)

March 23, 2009 updated by: Nile Therapeutics

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Russia
      • Moscow, Russia, Russian Federation, 121552
        • Russian Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cardiac output and wedge pressure
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in additional hemodynamic measures
Time Frame: 8 hours
8 hours
Diuresis and natriuresis during and after administration of study drug
Time Frame: 36 hour
36 hour
Safety of CD-NP
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nile Therapeutics

Collaborators

Momentum Research, Inc.

Investigators

  • Study Director: Hsiao Lieu, MD, Nile Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 23, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIL-CDNP-CT003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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