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

Acute Decompensated Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839007
• Other study ID #: NIL-CDNP-CT005
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2009
• Last updated: September 15, 2010
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Nile Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Drug:
• CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nile Therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.		Up to 72 hours	Yes

External Links

•   Sponsor website