Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

May 2, 2012 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.).

Study Overview

Status

Completed

Conditions

Heart Failure, Congestive

Intervention / Treatment

Drug: tolvaptan

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

Study Chair: James Udelson, MD, Cardiovascular Clinical Studies and Tufts/New England Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

156-04-247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.