Safety Study of CD-NP in Heart Failure

Phase 1

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00557661
• Lead Sponsor: Nile Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-12
• Study First Posted: 2007-11-14
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-23
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of CD-NP infusions in patients with heart failure	28 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion	24 hrs