Sponsor study identifier
interventional
20
1 country
1
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
October 13, 2005
Actual (reported)October 17, 2005
Actual (reported)November 2005
Actual (reported)November 2005
Actual (reported)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
Single arm study. 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute.
administration of IV nesiritide
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Rochester Medical Center
Rochester, New York, 14642, United States
Leway Chen, MD
University of Rochester
20 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2005
First Posted
October 17, 2005
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Contact the study team to confirm eligibility.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)Last Updated
June 19, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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