Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
NCT ID: NCT00132886
Last Updated: 2012-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2004-12-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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tolvaptan
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction less than or equal to 40%
* Currently being treated for heart failure with standard therapies for at least one month
Exclusion Criteria
* Inability to take oral medications
* Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
* Hypertrophic obstructive cardiomyopathy
* Severe obstructive pulmonary disease
* Significant renal impairment
* Significant uncorrected valvular or congenital heart disease
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Principal Investigators
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James Udelson, MD
Role: STUDY_CHAIR
Cardiovascular Clinical Studies and Tufts/New England Medical Center
Locations
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Oracle Research, A Div of the Heart Center
Huntsville, Alabama, United States
Merced Heart Associates
Merced, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Cardiovascular Center at Shands Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
ACRI
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Robert Rush University Medical Center
Chicago, Illinois, United States
Loyola University of Chicago
Maywood, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Cardiologist Institute
Slidell, Louisiana, United States
Medical Research Institute Louisiana Heart Hospital
Slidell, Louisiana, United States
Primary Cardiology Associates
Ayer, Massachusetts, United States
U-MASS Memorial Medical Center
Worchester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Heart Consultants, PC
Omaha, Nebraska, United States
University of Medicine and Dentistry
Newark, New Jersey, United States
UNC Heart Failure Program
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland VA Medical Center
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Guthrie Foundation
Syre, Pennsylvania, United States
Texas Heart Institute
Houston, Texas, United States
Southeast Texas Clinical Research
Orange, Texas, United States
Spitalul Clinic Urgenta
Bucharest, , Romania
Institutul de Boli Cardiovasculare
Bucharest, , Romania
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
Bucharest, , Romania
Institutul Inimii
Judetul Cluj, , Romania
Institutul de Boli Cardiovasculare si Transplant
Judetul Mures, , Romania
Countries
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References
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Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Jarvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol. 2008 Dec 16;52(25):2190-7. doi: 10.1016/j.jacc.2008.09.049.
Udelson JE, Orlandi C, Ouyang J, Krasa H, Zimmer CA, Frivold G, Haught WH, Meymandi S, Macarie C, Raef D, Wedge P, Konstam MA, Gheorghiade M. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Nov 4;52(19):1540-5. doi: 10.1016/j.jacc.2008.08.013.
Other Identifiers
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156-04-247
Identifier Type: -
Identifier Source: org_study_id
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