ID

11971

Description

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

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Versions (3)

1. 12/11/13 12/11/13 - Martin Dugas
2. 8/7/14 8/7/14 - Martin Dugas
3. 8/27/15 8/27/15 - Martin Dugas

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August 27, 2015

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