Abstract

Endothelin is a naturally occurring hormone which is a potent vasoconstrictor. BMS-193884 is a highly selective endothelin (ET) receptor antagonist. The primary indication for this drug will be as an adjunct to standard-triple therapy (digoxin,diuretics, and angiotensin converting enzyme inhibitor [ACE])in the treatment of heart failure. Patients with severe heart failure have elevated plasma ET level. The magnitude of the elevated ET is positively correlated with New York Heart Association (NYHA) Functional Class and left ventricular end-diastolic volume. Plasma ET levels have also been shown to be inversely related to left ventricular ejection fraction, cardiac index, and survival. BMS-193884 has the potential to ameliorate the clinical signs and symptoms of heart failure by vasodilation. BMS-193884 selectively binds to and antagonizes the ET receptors responsible for vasoconstriction (ET). Tissue perfusion is improved. The primary objective of this study is to evaluate the dose related hemodynamic response of BMS-193884 in subjects with heart failure (NYHA II-IV and an EF <35%. This is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the hemodynamic effects and safety of a single oral dose of either 5,10,25,50,100, or 200 mg of the endothelin receptor antagonist BMS-193884 in patients with heart failure

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000645-29
Application #
6307038
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
29
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

Melhem, Nadine M; Keilp, John G; Porta, Giovanna et al. (2016) Blunted HPA Axis Activity in Suicide Attempters Compared to those at High Risk for Suicidal Behavior. Neuropsychopharmacology 41:1447-56
Dong, Chuanhui; Della-Morte, David; Rundek, Tatjana et al. (2016) Evidence to Maintain the Systolic Blood Pressure Treatment Threshold at 140 mm?Hg for Stroke Prevention: The Northern Manhattan Study. Hypertension 67:520-6
Buckley, Jessie P; Engel, Stephanie M; Braun, Joseph M et al. (2016) Prenatal Phthalate Exposures and Body Mass Index Among 4- to 7-Year-old Children: A Pooled Analysis. Epidemiology 27:449-58
Leung, Vivien; Chiu, Ya-Lin; Kotler, Donald P et al. (2016) Effect of Recombinant Human Growth Hormone and Rosiglitazone for HIV-Associated Abdominal Fat Accumulation on Adiponectin and other Markers of Inflammation. HIV Clin Trials 17:55-62
Rosenbaum, Michael; Leibel, Rudolph L (2016) Models of energy homeostasis in response to maintenance of reduced body weight. Obesity (Silver Spring) 24:1620-9
Garyu, Justin W; Meffre, Eric; Cotsapas, Chris et al. (2016) Progress and challenges for treating Type 1 diabetes. J Autoimmun 71:1-9
Widen, Elizabeth M; Whyatt, Robin M; Hoepner, Lori A et al. (2016) Gestational weight gain and obesity, adiposity and body size in African-American and Dominican children in the Bronx and Northern Manhattan. Matern Child Nutr 12:918-28
Maresca, Michelle M; Hoepner, Lori A; Hassoun, Abeer et al. (2016) Prenatal Exposure to Phthalates and Childhood Body Size in an Urban Cohort. Environ Health Perspect 124:514-20
Tooley, James E; Vudattu, Nalini; Choi, Jinmyung et al. (2016) Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol 46:230-41
Branis, Natalia M; Etesami, Marjan; Walker, Ryan W et al. (2015) Effect of a 1-week, eucaloric, moderately high-fat diet on peripheral insulin sensitivity in healthy premenopausal women. BMJ Open Diabetes Res Care 3:e000100

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