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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00071331
First received: October 20, 2003
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
Drug: Tolvaptan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Estimated Enrollment: 3600
Study Start Date: September 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071331

  Show 378 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00071331     History of Changes
Other Study ID Numbers: 156-03-236
Study First Received: October 20, 2003
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
chronic heart failure
heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014