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Safety Study of CD-NP in Heart Failure

Primary Purpose

Congestive Heart Failure

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CD-NP

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart failure, CD-NP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00557661

First Posted

November 12, 2007

Last Updated

March 23, 2009

Sponsor

Nile Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00557661

Brief Title

Safety Study of CD-NP in Heart Failure

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nile Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

Heart failure, CD-NP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CD-NP

Intervention Description

24 hr intravenous infusion

Primary Outcome Measure Information:

Title

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

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

Time Frame

24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Goldsmith, MD

Organizational Affiliation

Hennepin County Medical Center, Minneapolis

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Safety Study of CD-NP in Heart Failure

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