Congestive Heart Failure
Conditions
Keywords
chronic heart failure, heart failure
Brief summary
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
Detailed description
Study Design: Multicenter, randomized, double-blind, placebo-controlled
Interventions
DRUGTolvaptan
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years. * Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization. The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (\>1+); or c) dyspnea. * NYHA Class III or IV at the time of hospitalization. * Left Ventricular Ejection Fraction \< = 40% within one year.
Exclusion criteria
* Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form. * Positive urine pregnancy test. * Inability to provide written informed consent. * Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions. * Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment. * Subjects who are on cardiac mechanical support. * History of bi-ventricular pacer placement within the last 60 days. * Co-morbid condition with an expected survival less than six months. * Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization. * History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator. * History of a cerebrovascular accident within the last 30 days. * Hemodynamically significant uncorrected primary cardiac valvular disease. * Hypertrophic cardiomyopathy (obstructive or non-obstructive). * CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy. * Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes. * History of primary significant liver disease or acute hepatic failure, as defined by the investigator. * History of poorly controlled diabetes mellitus. * Morbid obesity, defined as \> 159 kg (or 350 lbs) or BMI \> 40. * Supine systolic arterial blood pressure \< 90 mmHg. * Serum creatinine \> 3.5 mg/dL or \> 309.4 mmol/L. * Serum potassium \> 5.5 mEq/L or \> 5.5 mmol/L. * Hemoglobin \< 9 g/dL or \< 90 g/L. * History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril). * History of drug or medication abuse within the past year, or current alcohol abuse. * Inability to take oral medications. * Participation in another clinical drug or device trial within the past 30 days. * Previous participation in this or any other tolvaptan clinical trial.
Countries
Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed