Nesiritide and Vo2 Max in Heart Failure Patients

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Leway Chen, University of Rochester
ClinicalTrials.gov Identifier:
NCT00240084
First received: October 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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 Phase
Heart Failure
Drug: nesiritide (Natrecor(TM))
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nesiritide and Vo2 Max in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Peak VO2 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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).


Enrollment: 20
Study Start Date: July 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: nesiritide (Natrecor(TM))

Detailed Description:

See above comments.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

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

Responsible Party: Leway Chen, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00240084     History of Changes
Other Study ID Numbers: NES V02
Study First Received: October 13, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014