NCT00145873

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Aug 2003

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 8, 2013

Status Verified

September 1, 2006

Enrollment Period

3.1 years

First QC Date

September 1, 2005

Last Update Submit

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:
  • 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.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

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 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

October 8, 2013

Record last verified: 2006-09

Locations

US(1)