Heart Failure Clinical Trial

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

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.).

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00132886

Recruitment Status:

Completed

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

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There are 28 Locations for this study

See Locations Near You

Oracle Research, A Div of the Heart Center
Huntsville Alabama, 35801, United States
Merced Heart Associates
Merced California, 95340, United States
Olive View-UCLA Medical Center
Sylmar California, 91324, United States
Broward General Medical Center
Ft. Lauderdale Florida, 33316, United States
Cardiovascular Center at Shands Jacksonville
Jacksonville Florida, 32209, United States
Tampa General Hospital
Tampa Florida, 33606, United States
ACRI
Atlanta Georgia, 30342, United States
Northwestern University
Chicago Illinois, 60612, United States
Robert Rush University Medical Center
Chicago Illinois, 60612, United States
Loyola University of Chicago
Maywood Illinois, 60153, United States
University of Iowa Health Care
Iowa City Iowa, 52242, United States
Cardiologist Institute
Slidell Louisiana, 70458, United States
Medical Research Institute Louisiana Heart Hospital
Slidell Louisiana, 70458, United States
Primary Cardiology Associates
Ayer Massachusetts, 01432, United States
U-MASS Memorial Medical Center
Worchester Massachusetts, 01655, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Washington University School of Medicine
St. Louis Missouri, 63110, United States
Heart Consultants, PC
Omaha Nebraska, 68122, United States
University of Medicine and Dentistry
Newark New Jersey, 07103, United States
UNC Heart Failure Program
Chapel Hill North Carolina, 27517, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Cleveland VA Medical Center
Cleveland Ohio, 44106, United States
Oregon Health Sciences University
Portland Oregon, 97239, United States
Guthrie Foundation
Syre Pennsylvania, 18840, United States
Texas Heart Institute
Houston Texas, 77702, United States
Southeast Texas Clinical Research
Orange Texas, 77702, United States
Spitalul Clinic Urgenta
Bucuresti , 01446, Romania
Institutul de Boli Cardiovasculare
Bucuresti , 02232, Romania
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
Bucuresti , Cod 0, Romania
Institutul Inimii
Judetul Cluj , Cod 4, Romania
Institutul de Boli Cardiovasculare si Transplant
Judetul Mures , Cod 5, Romania

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00132886

Recruitment Status:

Completed

Sponsor:


Otsuka Pharmaceutical Development & Commercialization, Inc.

How clear is this clinincal trial information?

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