Clinical trial NCT00132886: Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure, Congestive
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).


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

Primary outcomes:
measure: Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Secondary outcomes:
measure: Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
measure: Change in urine output and free water clearance
measure: Change from baseline in urine osmolality
measure: Cmax, tmax, and AUC 12h of tolvaptan in plasma
measure: Adverse events, vital signs and clinical labs
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Oracle Research, A Div of the Heart Center
state: Alabama
city: Merced
country: United States
facility: Merced Heart Associates
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Ft. Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Cardiovascular Center at Shands Jacksonville
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: ACRI
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Robert Rush University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Slidell
country: United States
facility: Cardiologist Institute
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute Louisiana Heart Hospital
state: Louisiana
city: Ayer
country: United States
facility: Primary Cardiology Associates
state: Massachusetts
city: Worchester
country: United States
facility: U-MASS Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Heart Consultants, PC
state: Nebraska
city: Newark
country: United States
facility: University of Medicine and Dentistry
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Heart Failure Program
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland VA Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Syre
country: United States
facility: Guthrie Foundation
state: Pennsylvania
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Orange
country: United States
facility: Southeast Texas Clinical Research
state: Texas
city: Bucuresti
country: Romania
facility: Spitalul Clinic Urgenta
city: Bucuresti
country: Romania
facility: Institutul de Boli Cardiovasculare
city: Bucuresti
country: Romania
facility: Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
city: Judetul Cluj
country: Romania
facility: Institutul Inimii
city: Judetul Mures
country: Romania
facility: Institutul de Boli Cardiovasculare si Transplant
Study officials:
affiliation: Cardiovascular Clinical Studies and Tufts/New England Medical Center
name: James Udelson, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Udelson 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.