Safety Study of CD-NP in Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557661
• Other study ID #: NIL-CDNP-CT002
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2007
• Last updated: March 23, 2009
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Nile Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Male or female =18 years of age diagnosed with NYHA class III or IV heart failure in the last six months

• Female patients must be post-menopausal or surgically sterile

• Diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload

Key Exclusion Criteria:

• Women who are pregnant, breast-feeding or of child-bearing potential

• Clinically unstable patients

• Major surgical procedures within 30 days of entry

• Febrile temp > 100 degrees F)

• Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry

• Currently on IV vasoactive support (e.g., heart transplant candidate)

• History of unexplained syncope within the past 3 months

• History of organ transplantation

• Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.

• Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.

• Treatment with nesiritide within 14 days prior to dosing.

• Inability to effectively communicate with study personnel.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• CD-NP
24 hr intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nile Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of CD-NP infusions in patients with heart failure		28 days
Secondary	To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion		24 hrs