Status:
COMPLETED
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Lead Sponsor:
Nile Therapeutics
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 A...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00839007
Start Date
June 1 2009
End Date
July 1 2010
Last Update
September 17 2010
Active Locations (21)
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1
Los Angeles, California, United States, 90033
2
Torrance, California, United States, 90509
3
Jacksonville, Florida, United States, 32216
4
Miami Beach, Florida, United States, 33149