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Sponsors and Collaborators: |
University of Rochester Scios, Inc. |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00240084 |
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 |
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Heart Failure |
Drug: nesiritide (Natrecor(TM)) |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Nesiritide and Vo2 Max in Heart Failure Patients |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Leway Chen, MD | University of Rochester |
Study ID Numbers: | NES V02 |
Study First Received: | October 13, 2005 |
Last Updated: | September 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00240084 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Cardiovascular Agents |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Natriuretic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |