Safety Study of CD-NP in Heart Failure

Sponsor

Nile Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00557661

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Drug: CD-NP	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2007

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

To assess the safety and tolerability of CD-NP infusions in patients with heart failure [28 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nile Therapeutics

Investigators

Principal Investigator: Steven Goldsmith, MD, Hennepin County Medical Center, Minneapolis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00557661

Other Study ID Numbers:

NIL-CDNP-CT002

First Posted:

Nov 14, 2007

Last Update Posted:

Mar 25, 2009

Last Verified:

Mar 1, 2009

Keywords provided by , ,

Heart failure

CD-NP

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Mar 25, 2009