Congestive Heart Failure
Conditions
Keywords
Heart failure, CD-NP
Brief summary
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.
Interventions
DRUGCD-NP
24 hr intravenous infusion
Sponsors
Nile Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of CD-NP infusions in patients with heart failure | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion | 24 hrs |
Outcome results
None listed