Safety Study of CD-NP in Heart Failure

March 23, 2009 updated by: Nile Therapeutics

A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure

An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of CD-NP infusions in patients with heart failure
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nile Therapeutics

Investigators

  • Principal Investigator: Steven Goldsmith, MD, Hennepin County Medical Center, Minneapolis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 12, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 23, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIL-CDNP-CT002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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