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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

See above comments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nesiritide (Natrecor(TM))

Drug

administration of IV nesiritide

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

Scios, Inc.

Registry information

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Oct 17, 2005
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed