NCT00240084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Jul 2003

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

October 13, 2005

Last Update Submit

June 17, 2013

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Nesiritide infusion

EXPERIMENTAL

Single arm study. 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute.

Drug: nesiritide (Natrecor(TM))

Interventions

nesiritide (Natrecor(TM))DRUG

administration of IV nesiritide

Nesiritide infusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Leway Chen, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

July 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)