Nesiritide and Vo2 Max in Heart Failure Patients

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: NCT00240084
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : June 19, 2013
Scios, Inc.
Information provided by (Responsible Party):
Leway Chen, University of Rochester

Brief Summary:
This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized for exercise workload) in HF patients during and after exercise. However, trials involving the measurement of exercise capacity in this population following BNP administration are lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of 20 patients, all serving as their own controls. This study involves off-label use of the drug nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and Transplantation clinical service, who meet all the inclusion criteria and none of the exclusion criteria may participate in the study. Enrolled study subjects perform an exercise VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max test.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: nesiritide (Natrecor(TM)) Phase 2

Detailed Description:
See above comments.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nesiritide and Vo2 Max in Heart Failure Patients
Study Start Date : July 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Nesiritide infusion
Single arm study. 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute.
Drug: nesiritide (Natrecor(TM))
administration of IV nesiritide

Primary Outcome Measures :
  1. Peak VO2 [ Time Frame: 24 hours ]
    The goal of this study is to determine whether a continuous 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute will produce a significant improvement in exercise capacity as defined by maximum oxygen consumption (VO2 peak).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18-65 with NYHA Class II or III heart failure
  • Referred to Strong Memorial Hospital for consideration of heart transplant
  • Male or female and infertile or using effective contraception with negative pregnancy test
  • Capable of IV access
  • Able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
  • Fully understands and has signed Informed Consent Form before study begins
  • Endogenous BNP level of at least 100 pg/mL
  • Current smokers smoking < 3 cigarettes / day. Smoking is not permitted within the hospital, ergo subjects would not be permitted to smoke during study participation.

Exclusion Criteria:

  • NYHA Class i or IV heart failure
  • Creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of the study
  • EF > 40%
  • Evidence of primary lung disease
  • Hypersensitivity to nesiritide or any of its' components
  • Current smokers as defined by > 3 cigarettes / day
  • Stroke within 3 months, myocardial infarction within 2 months, or any evidence of active myocardial ischemia
  • Unwillingness ir inability to remain in the hospital overnight
  • Clinical condition or laboratory abnormality which may increase risks associated with participation or interfere with result interpretation
  • Any condition which would preclude heart transplantation.

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): NCT00240084

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Scios, Inc.
Principal Investigator: Leway Chen, MD University of Rochester

Responsible Party: Leway Chen, MD, University of Rochester Identifier: NCT00240084     History of Changes
Other Study ID Numbers: NES V02
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

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