Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
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
1 other identifier
interventional
140
2 countries
31
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.).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 18, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 3, 2012
May 1, 2012
2 years
August 18, 2005
May 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
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
Fort 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
Bucharest, 014461, Romania
Institutul de Boli Cardiovasculare
Bucharest, 022322, Romania
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
Bucharest, Cod 022322, Romania
Institutul Inimii
Judetul Cluj, Cod 400001, Romania
Institutul de Boli Cardiovasculare si Transplant
Judetul Mures, Cod 540136, Romania
Related Publications (2)
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.
PMID: 19095138DERIVEDUdelson 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.
PMID: 19007589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James Udelson, MD
Cardiovascular Clinical Studies and Tufts/New England Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2005
First Posted
August 22, 2005
Study Start
December 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
May 3, 2012
Record last verified: 2012-05