Nesiritide in Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145873
Recruitment Status : Terminated (Unable to complete study)
First Posted : September 5, 2005
Last Update Posted : October 8, 2013
Scios, Inc.
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: nesiritide, continuous infusion Phase 2

Detailed Description:

This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure. This study will only take place at the University of Chicago Hospitals. It is double-blinded, which means that the neither subject nor their study doctor will know which study drug the subject will receive. However, in an emergency, this information can be obtained quickly. The study is placebo-controlled, which means subjects will not receive study drug at some point during the study; however because it is a cross-over study, subjects will be receiving nesiritide at some point in the study. Subjects will receive the study drug nesiritide for six out of the 12 weeks of the study—either the first six weeks or the last six weeks.

The procedures for the study consist of: informed consent, questions about the subjects heart failure, blood sample, assessment of heart failure severity based on symptoms, six minute walk test and the Minnesota Living with Heart Failure Questionnaire, history of heart failure symptoms and emergency room visits, diuretic and baseline medication history, long term IV for medication infusions, adjustment of study drug and regularly taken medications, 6 weeks of receiving long term IV infusion of drug, blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians.

Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval. Baseline data, obtained from medical records will be recorded as will the number of hospitalizations/ER visits and NYHA class during the study period. These subjects will be surveyed by telephone monthly for the duration of the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago (CINCH-UC)
Study Start Date : August 2003
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in NYHA status [ Time Frame: Day 0, Day 42 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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:

  1. 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).
  2. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145873

United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Scios, Inc.
Principal Investigator: Allen Anderson, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00145873     History of Changes
Other Study ID Numbers: 12350A
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2006

Keywords provided by University of Chicago:
heart failure
heart disease
cardiovascular disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs