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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)

Primary Purpose

Acute Decompensated Heart Failure

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
CD-NP (Chimeric natriuretic peptide)
Sponsored by
Nile Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring ADHF, AHF, HF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Russian Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Open-label regimen of doses 1 and 2 of CDNP

Open-label regimen of doses 2 and 3 of CDNP

Open-label regimen of doses 3 and 4 of CDNP

Outcomes

Primary Outcome Measures

Changes in cardiac output and wedge pressure

Secondary Outcome Measures

Changes in additional hemodynamic measures
Diuresis and natriuresis during and after administration of study drug
Safety of CD-NP

Full Information

First Posted
June 10, 2008
Last Updated
March 23, 2009
Sponsor
Nile Therapeutics
Collaborators
Momentum Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00699712
Brief Title
Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Acronym
PreCONDITION
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nile Therapeutics
Collaborators
Momentum Research, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
ADHF, AHF, HF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Open-label regimen of doses 1 and 2 of CDNP
Arm Title
B
Arm Type
Experimental
Arm Description
Open-label regimen of doses 2 and 3 of CDNP
Arm Title
C
Arm Type
Experimental
Arm Description
Open-label regimen of doses 3 and 4 of CDNP
Intervention Type
Drug
Intervention Name(s)
CD-NP (Chimeric natriuretic peptide)
Intervention Description
Infusion of CDNP at two of four doses
Primary Outcome Measure Information:
Title
Changes in cardiac output and wedge pressure
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Changes in additional hemodynamic measures
Time Frame
8 hours
Title
Diuresis and natriuresis during and after administration of study drug
Time Frame
36 hour
Title
Safety of CD-NP
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao Lieu, MD
Organizational Affiliation
Nile Therapeutics Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gad Cotter, MD
Organizational Affiliation
Momentum Research, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Russian Academy of Medical Sciences
City
Moscow
State/Province
Russia
ZIP/Postal Code
121552
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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