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Nesiritide and Vo2 Max in Heart Failure Patients
This study has been completed.
First Received: October 13, 2005   Last Updated: September 27, 2006   History of Changes
Sponsors and Collaborators: University of Rochester
Scios, Inc.
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00240084
  Purpose

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 Intervention
Heart Failure
Drug: nesiritide (Natrecor(TM))

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Nesiritide and Vo2 Max in Heart Failure Patients
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240084

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

No publications provided

Study ID Numbers: NES V02
Study First Received: October 13, 2005
Last Updated: September 27, 2006
ClinicalTrials.gov Identifier: NCT00240084     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Cardiovascular Agents

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

ClinicalTrials.gov processed this record on May 07, 2009