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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071331
Recruitment Status : Completed
First Posted : October 21, 2003
Last Update Posted : May 3, 2012
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Tolvaptan Phase 3

Detailed Description:
Study Design: Multicenter, randomized, double-blind, placebo-controlled

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Study Type : Interventional  (Clinical Trial)
Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Study Start Date : September 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071331

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00071331    
Other Study ID Numbers: 156-03-236
First Posted: October 21, 2003    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
chronic heart failure
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs