Nesiritide and Vo2 Max in Heart Failure Patients

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: nesiritide (Natrecor(TM))

Detailed Description

See above comments.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2	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).	24 hours

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Scios, Inc.
• Investigators: Principal Investigator: Leway Chen, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID Numbers: NES V02