Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Primary Purpose
Acute Decompensated Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CD-NP
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:
- Hospitalized for acute decompensated heart failure.
- Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
- Renally compromised.
- Female patients must be post-menopausal or surgically sterile.
Key Exclusion Criteria:
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
- Cardiogenic shock
- Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
- Clinically significant aortic or mitral valve stenosis
- Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
- ADHF due to significant arrhythmias
- Severe renal failure defined as creatinine clearance < 30 mL/min
- Current or planned ultrafiltration, hemofiltration, or dialysis
- Significant pulmonary disease
- Major neurologic event, including cerebrovascular events in the prior 60 days.
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
- Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
D
E
F
G
Arm Description
Dose 1 of CD-NP
Dose 2 of CD-NP
Dose 3 of CD-NP
Dose 4 of CD-NP
Dose 5 of CD-NP
Dose 6 of CD-NP
Placebo
Outcomes
Primary Outcome Measures
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00839007
Brief Title
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Official Title
A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nile Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.
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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Dose 1 of CD-NP
Arm Title
B
Arm Type
Experimental
Arm Description
Dose 2 of CD-NP
Arm Title
C
Arm Type
Experimental
Arm Description
Dose 3 of CD-NP
Arm Title
D
Arm Type
Experimental
Arm Description
Dose 4 of CD-NP
Arm Title
E
Arm Type
Experimental
Arm Description
Dose 5 of CD-NP
Arm Title
F
Arm Type
Experimental
Arm Description
Dose 6 of CD-NP
Arm Title
G
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CD-NP
Intervention Description
Infusion of CD-NP at one of up to 6 doses or placebo
Primary Outcome Measure Information:
Title
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
Time Frame
Up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Hospitalized for acute decompensated heart failure.
Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
Renally compromised.
Female patients must be post-menopausal or surgically sterile.
Key Exclusion Criteria:
Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
Cardiogenic shock
Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
Clinically significant aortic or mitral valve stenosis
Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
ADHF due to significant arrhythmias
Severe renal failure defined as creatinine clearance < 30 mL/min
Current or planned ultrafiltration, hemofiltration, or dialysis
Significant pulmonary disease
Major neurologic event, including cerebrovascular events in the prior 60 days.
Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao Lieu, MD
Organizational Affiliation
Nile Therapeutics
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33149
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Berlin
ZIP/Postal Code
12351
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
City
Neuss
ZIP/Postal Code
41464
Country
Germany
City
Wuerzberg
ZIP/Postal Code
97080
Country
Germany
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
City
Safed
ZIP/Postal Code
13100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
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