Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
1 other identifier
interventional
170
2 countries
40
Brief Summary
The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2002
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 13, 2002
CompletedFirst Posted
Study publicly available on registry
August 14, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedJune 24, 2005
June 1, 2005
August 13, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (40)
Desert Cardiology of Tucson
Tucson, Arizona, 85741, United States
Arkansas Heart
Little Rock, Arkansas, 72211, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Northern California Medical Associates
Santa Rosa, California, 95403, United States
Cardiovascular Consultants Medical Group, Inc.
Walnut Creek, California, 94598, United States
University of Colorado
Denver, Colorado, 80262, United States
The Hoffman Heart Institute of CT/St. Francis Hospital
Hartford, Connecticut, 06105, United States
Yale University
New Haven, Connecticut, 06510, United States
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, 33308, United States
Cardiovascular Research Center of South Florida
Miami, Florida, 33173, United States
Charlotte Heart Group
Port Charlotte, Florida, 33952, United States
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, 33701, United States
Cardiovascular Associates of Augusta, PA
Augusta, Georgia, 30901, United States
Georgia Heart Specialists
Covington, Georgia, 30014, United States
Illinois Heart and Lung Associates, SC
Normal, Illinois, 61761, United States
The Care Group, LLC
Indianapolis, Indiana, 46260, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Androscoggin Cardiology Associates
Auburn, Maine, 04210, United States
Maine Cardiology Associates
Portland, Maine, 04102, United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01839, United States
Mystic Cardiology Associates, Inc.
Medford, Massachusetts, 02155, United States
Harper Hospital/Wayne State University
Detroit, Michigan, 48201, United States
John Dingell VA Medical Center
Detroit, Michigan, 48201, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025, United States
South Bay Cardiovascular Associates
West Islip, New York, 11795, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Midwest Cardiology Research Foundation
Columbus, Ohio, 43202, United States
North Ohio Research LTD
Lorraine, Ohio, 44053, United States
North Ohio Research LTD.
Sandusky, Ohio, 44870, United States
Medical College of Pennsylvania
Philadelphia, Pennsylvania, 19129, United States
Guthrie Clinic, LTD
Sayre, Pennsylvania, 18840, United States
Miriam Hospital
Providence, Rhode Island, 02905, United States
University Cardiology Foundation
Providence, Rhode Island, 02905, United States
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401, United States
Stern Cardiovascular Center
Memphis, Tennessee, 38120, United States
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9, Canada
Health Sciences Center Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
London Health Sciences Center
London, Ontario, N6A 4G5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
The Toronto Hospital
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
Udelson JE, McGrew FA, Flores E, Ibrahim H, Katz S, Koshkarian G, O'Brien T, Kronenberg MW, Zimmer C, Orlandi C, Konstam MA. Multicenter, randomized, double-blind, placebo-controlled study on the effect of oral tolvaptan on left ventricular dilation and function in patients with heart failure and systolic dysfunction. J Am Coll Cardiol. 2007 Jun 5;49(22):2151-9. doi: 10.1016/j.jacc.2007.01.091. Epub 2007 May 18.
PMID: 17543634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 13, 2002
First Posted
August 14, 2002
Study Start
July 1, 2002
Study Completion
July 1, 2004
Last Updated
June 24, 2005
Record last verified: 2005-06