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Safety Study of CD-NP in Heart Failure

This study has been completed.
Information provided by:
Nile Therapeutics Identifier:
First received: November 12, 2007
Last updated: March 23, 2009
Last verified: March 2009
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.

Condition Intervention Phase
Congestive Heart Failure Drug: CD-NP Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Nile Therapeutics:

Primary Outcome Measures:
  • To assess the safety and tolerability of CD-NP infusions in patients with heart failure [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion [ Time Frame: 24 hrs ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: December 2008
Intervention Details:
    Drug: CD-NP
    24 hr intravenous infusion

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00557661

Sponsors and Collaborators
Nile Therapeutics
Principal Investigator: Steven Goldsmith, MD Hennepin County Medical Center, Minneapolis
  More Information Identifier: NCT00557661     History of Changes
Other Study ID Numbers: NIL-CDNP-CT002
Study First Received: November 12, 2007
Last Updated: March 23, 2009

Keywords provided by Nile Therapeutics:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on July 21, 2017