Safety Study of CD-NP in Heart Failure

Nile Therapeutics

Status and phase

Completed

Phase 1

Conditions

Congestive Heart Failure

Treatments

Drug: CD-NP

Study type

Interventional

Funder types

Industry

Identifiers

NIL-CDNP-CT002

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.