Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132886
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : May 3, 2012
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: tolvaptan Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure
Study Start Date : December 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan

Primary Outcome Measures :
  1. Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary Outcome Measures :
  1. Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
  2. Change in urine output and free water clearance
  3. Change from baseline in urine osmolality
  4. Cmax, tmax, and AUC 12h of tolvaptan in plasma
  5. Adverse events, vital signs and clinical labs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with Class III or IV heart failure for at least 3 months
  • 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:

  • Women who are pregnant or breastfeeding
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132886

  Hide Study Locations
United States, Alabama
Oracle Research, A Div of the Heart Center
Huntsville, Alabama, United States, 35801
United States, California
Merced Heart Associates
Merced, California, United States, 95340
Olive View-UCLA Medical Center
Sylmar, California, United States, 91324
United States, Florida
Broward General Medical Center
Ft. Lauderdale, Florida, United States, 33316
Cardiovascular Center at Shands Jacksonville
Jacksonville, Florida, United States, 32209
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60612
Robert Rush University Medical Center
Chicago, Illinois, United States, 60612
Loyola University of Chicago
Maywood, Illinois, United States, 60153
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Louisiana
Cardiologist Institute
Slidell, Louisiana, United States, 70458
Medical Research Institute Louisiana Heart Hospital
Slidell, Louisiana, United States, 70458
United States, Massachusetts
Primary Cardiology Associates
Ayer, Massachusetts, United States, 01432
U-MASS Memorial Medical Center
Worchester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
Heart Consultants, PC
Omaha, Nebraska, United States, 68122
United States, New Jersey
University of Medicine and Dentistry
Newark, New Jersey, United States, 07103
United States, North Carolina
UNC Heart Failure Program
Chapel Hill, North Carolina, United States, 27517
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland VA Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Guthrie Foundation
Syre, Pennsylvania, United States, 18840
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77702
Southeast Texas Clinical Research
Orange, Texas, United States, 77702
Spitalul Clinic Urgenta
Bucuresti, Romania, 014461
Institutul de Boli Cardiovasculare
Bucuresti, Romania, 022322
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
Bucuresti, Romania, Cod 022322
Institutul Inimii
Judetul Cluj, Romania, Cod 400001
Institutul de Boli Cardiovasculare si Transplant
Judetul Mures, Romania, Cod 540136
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Chair: James Udelson, MD Cardiovascular Clinical Studies and Tufts/New England Medical Center