Safety Study of CD-NP in Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT00557661
First received: November 12, 2007
Last updated: March 23, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Safety Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557661

Sponsors and Collaborators
Nile Therapeutics
Investigators
Principal Investigator: Steven Goldsmith, MD Hennepin County Medical Center, Minneapolis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00557661     History of Changes
Other Study ID Numbers: NIL-CDNP-CT002
Study First Received: November 12, 2007
Last Updated: March 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Nile Therapeutics:
Heart failure
CD-NP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014