Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

Nile Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: CD-NP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839007

NIL-CDNP-CT005

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 7 patient groups, including a placebo group

A

Experimental group

Description:

Dose 1 of CD-NP

Treatment:

Drug: CD-NP

B

Experimental group

Description:

Dose 2 of CD-NP

Treatment:

Drug: CD-NP

C

Experimental group

Description:

Dose 3 of CD-NP

Treatment:

Drug: CD-NP

D

Experimental group

Description:

Dose 4 of CD-NP

Treatment:

Drug: CD-NP

E

Experimental group

Description:

Dose 5 of CD-NP

Treatment:

Drug: CD-NP

F

Experimental group

Description:

Dose 6 of CD-NP

Treatment:

Drug: CD-NP

G

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: CD-NP