EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

Completed · Phase 3

Conditions studied: Congestive Heart Failure

In brief

The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

Key facts

Study ID

NCT00071331

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

3600

Starts

2003-09-01

Expected to finish

2006-07-01

Last updated by the study team

2012-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Heart Center — Huntsville, Alabama, United States
• The Heart Group — Mobile, Alabama, United States
• Phoenix Memorial Hospital — Gilbert, Arizona, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• Saguaro Clinical Research — Tucson, Arizona, United States
• Central Arkansas Veterans Healthcare Systems — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Bakersfield Memorial Hospital — Bakersfield, California, United States
• Central Cardiology Medical Center — Bakersfield, California, United States
• Cardiology Associates — Larkspur, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• LAC/USC Medical Center — Los Angeles, California, United States
• VA Medical Center- W. Los Angeles — Los Angeles, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• ARI Clinical Trials — Redondo Beach, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• Pacific Heart Institute — Santa Monica, California, United States
• Cardiovascular Consultants Medical Group, Inc. — Walnut Creek, California, United States
• Aurora Denver Cardiology Associates — Denver, Colorado, United States
• University of Colorado — Denver, Colorado, United States
• Heart and Vascular Clinic of North Colorado — Fort Collins, Colorado, United States
• Bakus Resesarch — Norwich, Connecticut, United States
• Christiana Care Health System — Newark, Delaware, United States
• VA Medical Center — Washington D.C., District of Columbia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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