Safety Study of CD-NP in Heart Failure

NCT ID: NCT00557661

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-12-31

Brief Summary

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

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CD-NP

24 hr intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nile Therapeutics

INDUSTRY

Sponsor Role: lead

Principal Investigators

Steven Goldsmith, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Other Identifiers

NIL-CDNP-CT002

Identifier Type: -

Identifier Source: org_study_id