Clinical trial NCT00839007: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Decompensated Heart Failure
Keywords: ADHF
AHF
HF
Lead sponsor: Nile Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Hospitalized for acute decompensated heart failure.
2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
3. Renally compromised.
4. Female patients must be post-menopausal or surgically sterile.

Key Exclusion Criteria:

1. Acute or suspected acute myocardial infarction (AMI) or troponin levels \> 3X the upper limit of normal at the institution's local laboratory
2. Cardiogenic shock
3. Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
4. Clinically significant aortic or mitral valve stenosis
5. Temperature \>38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
6. ADHF due to significant arrhythmias
7. Severe renal failure defined as creatinine clearance \< 30 mL/min
8. Current or planned ultrafiltration, hemofiltration, or dialysis
9. Significant pulmonary disease
10. Major neurologic event, including cerebrovascular events in the prior 60 days.
11. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
12. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds

Primary outcomes:
measure: The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Bronx
country: United States
state: New York
city: Houston
country: United States
state: Texas
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Dortmund
country: Germany
city: Neuss
country: Germany
city: Wuerzberg
country: Germany
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Nazareth
country: Israel
city: Petach-Tikva
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
Study officials:
affiliation: Nile Therapeutics
name: Hsiao Lieu, MD
role: STUDY_DIRECTOR
References: