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

Keywords

  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
Uploaded on

August 27, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility Heart Failure EVEREST NCT00071331

Eligibility Heart Failure EVEREST NCT00071331

Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Age greater than or equal to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Chronic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0264722
NYHA Class III or IV at the time of hospitalization
Description

NYHA III-IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1319795
UMLS CUI [1,2]
C1319796
Left Ventricular Ejection Fraction <= 40% within one year
Description

Ejection Fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form
Description

Contraception failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009866
Positive urine pregnancy test
Description

Pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0549206
Inability to provide written informed consent
Description

Inability for consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions
Description

Cardiac surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018821
Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment
Description

Planned cardiac procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1279986
UMLS CUI [1,2]
C1301732
Subjects who are on cardiac mechanical support
Description

Cardiac mechanical support

Data type

boolean

Alias
UMLS CUI [1]
C0457617
History of bi-ventricular pacer placement within the last 60 days
Description

Bi-ventricular pacer

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0699808
Co-morbid condition with an expected survival less than six months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization
Description

Myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator
Description

Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0085612
History of a cerebrovascular accident within the last 30 days
Description

Stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
Hemodynamically significant uncorrected primary cardiac valvular disease
Description

Cardiac valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
Description

Hypertrophic cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
Description

Thyroid disease, active myocarditis or amyloid cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0040128
UMLS CUI [2]
C0238294
UMLS CUI [3]
C0268407
Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes
Description

Multiple Sclerosis | Stroke

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0038454
History of primary significant liver disease or acute hepatic failure, as defined by the investigator
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0085605
History of poorly controlled diabetes mellitus
Description

Diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40
Description

Obesity

Data type

boolean

Alias
UMLS CUI [1]
C0028754
Supine systolic arterial blood pressure < 90 mmHg
Description

Systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Serum potassium > 5.5 mEq/L or > 5.5 mmol/L
Description

Serum potassium

Data type

boolean

Alias
UMLS CUI [1]
C0202194
Hemoglobin < 9 g/dL or < 90 g/L
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0518015
History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril)
Description

Hypersensitivity to benzazepine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005034
History of drug or medication abuse within the past year, or current alcohol abuse
Description

Drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0237123
Inability to take oral medications
Description

Inability to take oral medications

Data type

boolean

Alias
UMLS CUI [1,1]
C3839225
Participation in another clinical drug or device trial within the past 30 days
Description

Other trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Previous participation in this or any other tolvaptan clinical trial
Description

Other tolvaptan trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1176308

Similar models

Eligibility Heart Failure EVEREST NCT00071331

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Age
Item
Age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Chronic congestive heart failure
Item
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
boolean
C0264722 (UMLS CUI [1])
NYHA III-IV
Item
NYHA Class III or IV at the time of hospitalization
boolean
C1319795 (UMLS CUI [1,1])
C1319796 (UMLS CUI [1,2])
Ejection Fraction
Item
Left Ventricular Ejection Fraction <= 40% within one year
boolean
C0232174 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Contraception failure
Item
Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form
boolean
C0009866 (UMLS CUI [1,1])
Pregnant
Item
Positive urine pregnancy test
boolean
C0549206 (UMLS CUI [1])
Inability for consent
Item
Inability to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Cardiac surgery
Item
Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions
boolean
C0018821 (UMLS CUI [1])
Planned cardiac procedures
Item
Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment
boolean
C1279986 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Cardiac mechanical support
Item
Subjects who are on cardiac mechanical support
boolean
C0457617 (UMLS CUI [1])
Bi-ventricular pacer
Item
History of bi-ventricular pacer placement within the last 60 days
boolean
C0030163 (UMLS CUI [1,1])
C0699808 (UMLS CUI [1,2])
Life expectancy
Item
Co-morbid condition with an expected survival less than six months
boolean
C0023671 (UMLS CUI [1])
Myocardial infarction
Item
Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization
boolean
C0027051 (UMLS CUI [1])
Ventricular arrhythmia
Item
History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator
boolean
C0085612 (UMLS CUI [1])
Stroke
Item
History of a cerebrovascular accident within the last 30 days
boolean
C0038454 (UMLS CUI [1])
Cardiac valvular disease
Item
Hemodynamically significant uncorrected primary cardiac valvular disease
boolean
C0018824 (UMLS CUI [1])
Hypertrophic cardiomyopathy
Item
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
boolean
C0007194 (UMLS CUI [1])
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Item
CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
boolean
C0040128 (UMLS CUI [1])
C0238294 (UMLS CUI [2])
C0268407 (UMLS CUI [3])
Multiple Sclerosis | Stroke
Item
Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes
boolean
C0026769 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Liver disease
Item
History of primary significant liver disease or acute hepatic failure, as defined by the investigator
boolean
C0085605 (UMLS CUI [1])
Diabetes mellitus
Item
History of poorly controlled diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Obesity
Item
Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40
boolean
C0028754 (UMLS CUI [1])
Systolic blood pressure
Item
Supine systolic arterial blood pressure < 90 mmHg
boolean
C0871470 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L
boolean
C0201976 (UMLS CUI [1])
Serum potassium
Item
Serum potassium > 5.5 mEq/L or > 5.5 mmol/L
boolean
C0202194 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin < 9 g/dL or < 90 g/L
boolean
C0518015 (UMLS CUI [1])
Hypersensitivity to benzazepine
Item
History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril)
boolean
C0020517 (UMLS CUI [1,1])
C0005034 (UMLS CUI [1,2])
Drug or alcohol abuse
Item
History of drug or medication abuse within the past year, or current alcohol abuse
boolean
C0237123 (UMLS CUI [1])
Inability to take oral medications
Item
Inability to take oral medications
boolean
C3839225 (UMLS CUI [1,1])
Other trial
Item
Participation in another clinical drug or device trial within the past 30 days
boolean
C2348568 (UMLS CUI [1])
Other tolvaptan trial
Item
Previous participation in this or any other tolvaptan clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C1176308 (UMLS CUI [1,2])

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