Safety Study of CD-NP in Heart Failure

NCT00557661 | Completed Phase 1

• 1 other identifier: NIL-CDNP-CT002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Heart failure; CD-NP

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of CD-NP infusions in patients with heart failure

  28 days

Secondary Outcomes (1)

• To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion

  24 hrs

Interventions

CD-NP DRUG

24 hr intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nile Therapeutics: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven Goldsmith, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 25, 2009

Record last verified: 2009-03