Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Completed · Phase 2

Conditions studied: Heart Failure, Congestive

In brief

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.).

Key facts

Study ID

NCT00132886

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

140

Starts

2004-12-01

Expected to finish

2006-12-01

Last updated by the study team

2012-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oracle Research, A Div of the Heart Center — Huntsville, Alabama, United States
• Merced Heart Associates — Merced, California, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• Cardiovascular Center at Shands Jacksonville — Jacksonville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• ACRI — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Robert Rush University Medical Center — Chicago, Illinois, United States
• Loyola University of Chicago — Maywood, Illinois, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Cardiologist Institute — Slidell, Louisiana, United States
• Medical Research Institute Louisiana Heart Hospital — Slidell, Louisiana, United States
• Primary Cardiology Associates — Ayer, Massachusetts, United States
• U-MASS Memorial Medical Center — Worchester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Heart Consultants, PC — Omaha, Nebraska, United States
• University of Medicine and Dentistry — Newark, New Jersey, United States
• UNC Heart Failure Program — Chapel Hill, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland VA Medical Center — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Guthrie Foundation — Syre, Pennsylvania, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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