Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00132886
First received: August 18, 2005
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Drug: tolvaptan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

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

Estimated Enrollment: 140
Study Start Date: December 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132886

  Hide Study Locations
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
ACRI
Atlanta, Georgia, United States, 30342
United States, Illinois
Robert Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern University
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
Medical Research Institute Louisiana Heart Hospital
Slidell, Louisiana, United States, 70458
Cardiologist Institute
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
Romania
Institutul de Boli Cardiovasculare
Bucuresti, Romania, 022322
Spitalul Clinic Urgenta
Bucuresti, Romania, 014461
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.
Investigators
Study Chair: James Udelson, MD Cardiovascular Clinical Studies and Tufts/New England Medical Center
  More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00132886     History of Changes
Other Study ID Numbers: 156-04-247
Study First Received: August 18, 2005
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014