Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00132886
- 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.).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in heart pressures (PCWP) at 3 to 8 hours post-dose
- Secondary Outcome Measures
Name Time Method Change in urine output and free water clearance Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose Adverse events, vital signs and clinical labs Cmax, tmax, and AUC 12h of tolvaptan in plasma Change from baseline in urine osmolality
Trial Locations
- Locations (31)
Robert Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Loyola University of Chicago
🇺🇸Maywood, Illinois, United States
Cleveland VA Medical Center
🇺🇸Cleveland, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cardiologist Institute
🇺🇸Slidell, Louisiana, United States
Medical Research Institute Louisiana Heart Hospital
🇺🇸Slidell, Louisiana, United States
Heart Consultants, PC
🇺🇸Omaha, Nebraska, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
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
🇺🇸Ft. Lauderdale, Florida, United States
Cardiovascular Center at Shands Jacksonville
🇺🇸Jacksonville, Florida, United States
ACRI
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, 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
University of Medicine and Dentistry
🇺🇸Newark, New Jersey, United States
UNC Heart Failure Program
🇺🇸Chapel Hill, North Carolina, United States
Guthrie Foundation
🇺🇸Syre, Pennsylvania, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Institutul de Boli Cardiovasculare
🇷🇴Bucuresti, Romania
Southeast Texas Clinical Research
🇺🇸Orange, Texas, United States
Spitalul Clinic Urgenta
🇷🇴Bucuresti, Romania
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
🇷🇴Bucuresti, Romania
Institutul de Boli Cardiovasculare si Transplant
🇷🇴Judetul Mures, Romania
Institutul Inimii
🇷🇴Judetul Cluj, Romania
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States