Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132886
• Other study ID #: 156-04-247
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2005
• Last updated: May 2, 2012
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2012
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• tolvaptan

Locations

Country	Name	City	State
Romania	Institutul de Boli Cardiovasculare	Bucuresti
Romania	Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"	Bucuresti
Romania	Spitalul Clinic Urgenta	Bucuresti
Romania	Institutul Inimii	Judetul Cluj
Romania	Institutul de Boli Cardiovasculare si Transplant	Judetul Mures
United States	ACRI	Atlanta	Georgia
United States	Primary Cardiology Associates	Ayer	Massachusetts
United States	UNC Heart Failure Program	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Robert Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland VA Medical Center	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Broward General Medical Center	Ft. Lauderdale	Florida
United States	Texas Heart Institute	Houston	Texas
United States	Oracle Research, A Div of the Heart Center	Huntsville	Alabama
United States	University of Iowa Health Care	Iowa City	Iowa
United States	Cardiovascular Center at Shands Jacksonville	Jacksonville	Florida
United States	Loyola University of Chicago	Maywood	Illinois
United States	Merced Heart Associates	Merced	California
United States	University of Medicine and Dentistry	Newark	New Jersey
United States	Heart Consultants, PC	Omaha	Nebraska
United States	Southeast Texas Clinical Research	Orange	Texas
United States	Oregon Health Sciences University	Portland	Oregon
United States	Cardiologist Institute	Slidell	Louisiana
United States	Medical Research Institute Louisiana Heart Hospital	Slidell	Louisiana
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Olive View-UCLA Medical Center	Sylmar	California
United States	Guthrie Foundation	Syre	Pennsylvania
United States	Tampa General Hospital	Tampa	Florida
United States	U-MASS Memorial Medical Center	Worchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Secondary	Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Secondary	Change in urine output and free water clearance
Secondary	Change from baseline in urine osmolality
Secondary	Cmax, tmax, and AUC 12h of tolvaptan in plasma
Secondary	Adverse events, vital signs and clinical labs