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
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring ADHF, AHF, HF
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
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
NCT ID
NCT00699712
First Posted
June 10, 2008
Last Updated
March 23, 2009
Sponsor
Nile Therapeutics
Collaborators
Momentum Research, Inc.
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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