Safety Study of CD-NP in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557661
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : March 25, 2009
Information provided by:
Nile Therapeutics

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 Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Intervention Details:
  • Drug: CD-NP
    24 hr intravenous infusion

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557661

Sponsors and Collaborators
Nile Therapeutics
Principal Investigator: Steven Goldsmith, MD Hennepin County Medical Center, Minneapolis Identifier: NCT00557661     History of Changes
Other Study ID Numbers: NIL-CDNP-CT002
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Nile Therapeutics:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases