NCT00145873

TerminatedPhase 2

Nesiritide in Chronic Heart Failure

University of Chicago Source

University of Chicago

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

12350A

Secondary identifiers

1

Study Type

interventional

Reported enrollment (type unavailable)

20

Locations

1 country

Sites

1

Timeline

Study Start

August 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

Study Completion

September 2006

Actual (reported)

Brief Summary

The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure. Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III \& IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period. Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing. Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Reported enrollment (type unavailable): 20 participants
Study completion date: September 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 1, 2005
Actual (reported)
First Posted
September 5, 2005
Actual (reported)
Primary Completion
September 2006
Actual (reported)
Study Completion
September 2006
Actual (reported)

Last Updated: October 8, 2013
Status Verified: September 2006
Last Update Submitted: October 7, 2013

Conditions

Heart Failure

Keywords

heart failurenesiritideheart diseasecardiovascular disease

Outcome Measures

Primary Outcomes (1)

Change in NYHA status
Day 0, Day 42

Interventions

nesiritide, continuous infusionDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Candidates for enrollment in this clinical trial are limited to adult patients (age\>21) diagnosed with chronic heart failure \> one year who are managed by heart failure specialists at the University of Chicago. Patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. Study patients are characterized as "high risk" by fulfilling one or more of the following criteria:

Sponsors & Collaborators

Scios, Inc.
Industrycollaborator
University of Chicago
Otherlead

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

MeSH Terms

Conditions

Heart FailureHeart DiseasesCardiovascular Diseases

Interventions

Natriuretic Peptide, Brain

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

Allen Anderson, MD
University of Chicago
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

August 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

NCT00091520

A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure

Phase 2Completed

NCT00573144

Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction

Phase 2Completed

NCT00585104

Myocardial Hemodynamic Effects of Levosimendan

Phase 2Completed

NCT00176384

Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure

Phase 2Completed

NCT03565328

The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects

Phase 2Terminated

NCT05177822

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Phase 2Active Not Recruiting

Refractory class III or IV heart failure despite optimal medical therapy by a heart failure specialist: Angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-adrenergic blockers (BB), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (CCB).

Frequent hospitalizations or ER visits (\>1/month on average).

Additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous IV infusion therapy with the assistance of home care nursing and the study coordinator.

You may not qualify if:

Nesiritide infusion \>24 hours in the previous 30 days.
Stable chronic heart failure or NYHA Class I or II.
Aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
Hypertrophic cardiomyopathy with an outflow tract gradient.
Isolated right heart failure (cor pulmonale).
Unstable coronary syndrome or myocardial infarction\< 3 months prior to enrollment.
Chronic hypotension with systolic blood pressure \< 80 mmHg.
Terminal noncardiovascular illness with life expectancy \<6 months. Moribund patients will not be considered for enrollment.
Active substance abuse.
Inadequate social support.
Contraindication to long term IV access.
Pregnant or lactating females.

Contact the study team to confirm eligibility.

Study Completion

September 2006

Actual (reported)

Last Updated

October 8, 2013

Record last verified: 2006-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00145873
Data provider: ClinicalTrials.gov
Source updated: 2013-10-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:17 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations