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Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tolvaptan
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oracle Research, A Div of the Heart Center
  • Merced Heart Associates
  • Olive View-UCLA Medical Center
  • Broward General Medical Center
  • Cardiovascular Center at Shands Jacksonville
  • Tampa General Hospital
  • ACRI
  • Northwestern University
  • Robert Rush University Medical Center
  • Loyola University of Chicago
  • University of Iowa Health Care
  • Cardiologist Institute
  • Medical Research Institute Louisiana Heart Hospital
  • Primary Cardiology Associates
  • U-MASS Memorial Medical Center
  • Henry Ford Hospital
  • Washington University School of Medicine
  • Heart Consultants, PC
  • University of Medicine and Dentistry
  • UNC Heart Failure Program
  • University of Cincinnati
  • Cleveland VA Medical Center
  • Oregon Health Sciences University
  • Guthrie Foundation
  • Texas Heart Institute
  • Southeast Texas Clinical Research
  • Spitalul Clinic Urgenta
  • Institutul de Boli Cardiovasculare
  • Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
  • Institutul Inimii
  • Institutul de Boli Cardiovasculare si Transplant

Outcomes

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

Full Information

First Posted
August 18, 2005
Last Updated
May 2, 2012
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00132886
Brief Title
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tolvaptan
Primary Outcome Measure Information:
Title
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Secondary Outcome Measure Information:
Title
Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Title
Change in urine output and free water clearance
Title
Change from baseline in urine osmolality
Title
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Title
Adverse events, vital signs and clinical labs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Udelson, MD
Organizational Affiliation
Cardiovascular Clinical Studies and Tufts/New England Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Oracle Research, A Div of the Heart Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Merced Heart Associates
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Broward General Medical Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Cardiovascular Center at Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
ACRI
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Robert Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University of Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cardiologist Institute
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Medical Research Institute Louisiana Heart Hospital
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Primary Cardiology Associates
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
U-MASS Memorial Medical Center
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Heart Consultants, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
University of Medicine and Dentistry
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
UNC Heart Failure Program
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland VA Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Guthrie Foundation
City
Syre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Southeast Texas Clinical Research
City
Orange
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Spitalul Clinic Urgenta
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Institutul de Boli Cardiovasculare
City
Bucuresti
ZIP/Postal Code
022322
Country
Romania
Facility Name
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
City
Bucuresti
ZIP/Postal Code
Cod 022322
Country
Romania
Facility Name
Institutul Inimii
City
Judetul Cluj
ZIP/Postal Code
Cod 400001
Country
Romania
Facility Name
Institutul de Boli Cardiovasculare si Transplant
City
Judetul Mures
ZIP/Postal Code
Cod 540136
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
19095138
Citation
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.
Results Reference
derived
PubMed Identifier
19007589
Citation
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.
Results Reference
derived

Learn more about this trial

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

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