ID
4582
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
Versions (3)
- 12/11/13 12/11/13 - Martin Dugas
- 8/7/14 8/7/14 - Martin Dugas
- 8/27/15 8/27/15 - Martin Dugas
Uploaded on
December 11, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00071331 Heart Failure
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
Reproductive precautions
Data type
boolean
Description
Pregnant
Data type
boolean
Description
Inability for consent
Data type
boolean
Description
Cardiac surgery
Data type
boolean
Description
Planned cardiac procedures
Data type
boolean
Description
Cardiac mechanical support
Data type
boolean
Description
Bi-ventricular pacer
Data type
boolean
Description
Life expectancy
Data type
boolean
Description
Myocardial infarction
Data type
boolean
Description
Ventricular arrhythmia
Data type
boolean
Description
Stroke
Data type
boolean
Description
Cardiac valvular disease
Data type
boolean
Description
Hypertrophic cardiomyopathy
Data type
boolean
Description
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Data type
boolean
Description
Multiple sclerosis, Stroke
Data type
boolean
Description
Liver disease
Data type
boolean
Description
Diabetes mellitus
Data type
boolean
Description
Obesity
Data type
boolean
Description
Systolic blood pressure
Data type
boolean
Description
Serum creatinine
Data type
boolean
Description
Serum potassium
Data type
boolean
Description
Hemoglobin
Data type
boolean
Description
Hypersensitivity to benzazepine
Data type
boolean
Description
Drug or alcohol abuse
Data type
boolean
Description
Inability to take oral medications
Data type
boolean
Description
Other trial
Data type
boolean
Description
Other tolvaptan trial
Data type
boolean
Description
Medizinische Konzepte
Description
Age
Data type
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Description
Chronic congestive heart failure
Data type
string
Alias
- UMLS CUI
- C0264722
- SNOMED CT 2010_0731
- 195110006
- ICD-10 Version 2009
- I50.0
Description
Jugular venous distention
Data type
string
Alias
- UMLS CUI
- C1719935
- SNOMED CT 2010_0731
- 422008005
Description
Pitting edema
Data type
string
Alias
- UMLS CUI
- C0333243
- SNOMED CT 2010_0731
- 139248000
- MedDRA 13.1
- 10054547
Description
Dyspnea
Data type
string
Alias
- UMLS CUI
- C0013404
- SNOMED CT 2010_0731
- 139201002
- MedDRA 13.1
- 10013963
- ICD-10-CM Version 2010
- R06.0
- CTCAE Version 4.03
- E13368
Description
New York Heart Association Classification
Data type
string
Alias
- UMLS CUI
- C1275491
- SNOMED CT 2010_0731
- 420816009
Description
Cardiac ejection fraction
Data type
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Description
pregnant
Data type
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Therapeutic procedure
Data type
string
Alias
- UMLS CUI
- C0087111
Description
Life expectancy
Data type
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Description
Acute myocardial infarction
Data type
string
Alias
- UMLS CUI
- C0155626
- SNOMED CT 2010_0731
- 57054005
- MedDRA 13.1
- 10000891
- ICD-10 Version 2009
- I21
- ICD-9-CM Version 2011
- 410
Description
Ventricular arrhythmia
Data type
string
Alias
- UMLS CUI
- C0085612
- SNOMED CT 2010_0731
- 44103008
- MedDRA 13.1
- 10047281
- ICD-10 Version 2009
- I47.2
- ICD-10-CM Version 2010
- I49.01
- CTCAE Version 4.03
- E10230
Description
Stroke
Data type
string
Alias
- UMLS CUI
- C0038454
- SNOMED CT 2010_0731
- 230690007
- MedDRA 13.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE Version 4.03
- E12826
Description
Hypertrophic cardiomyopathy
Data type
string
Alias
- UMLS CUI
- C0007194
- SNOMED CT 2010_0731
- 233873004
- MedDRA 13.1
- 10020871
Description
Weight
Data type
string
Alias
- UMLS CUI
- C1305866
- LOINC Version 232
- LP18015-5
- MedDRA 13.1
- 10047890
- SNOMED CT 2010_0731
- 107647005
Description
BMI
Data type
string
Alias
- UMLS CUI
- C1305855
- LOINC Version 232
- LP35925-4
- MedDRA 13.1
- 10005894
- SNOMED CT 2010_0731
- 140075008
Description
Arterial blood pressure
Data type
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Description
Low blood pressure
Data type
string
Alias
- UMLS CUI
- C0020649
- MedDRA 13.1
- 10003146
- SNOMED CT 2010_0731
- 45007003
- ICD-10-CM Version 2010
- I95
- ICD-9-CM Version 2011
- 458
Description
Creatinine
Data type
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Description
Potassium
Data type
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Description
Hemoglobin
Data type
string
Alias
- SNOMED CT 2010_0731
- 38082009
- UMLS CUI
- C0019046
- MedDRA 13.1
- 10019481
- LOINC
- LP14449-0
Description
Allergic reaction, due to correct medicinal substance properly administered
Data type
string
Alias
- UMLS CUI
- C0274302
- SNOMED CT 2010_0731
- 57302007
Description
Drug abuse
Data type
string
Alias
- UMLS CUI
- C0013146
- SNOMED CT 2010_0731
- 26416006
- MedDRA 13.1
- 10013654
- LOINC
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
Description
Alcohol abuse
Data type
string
Alias
- UMLS CUI
- C0085762
- SNOMED CT 2010_0731
- 15167005
- MedDRA 13.1
- 10001584
- LOINC
- LP36309-0
- ICD-9-CM Version 2011
- 305.0
- ICD-10-CM Version 2010
- F10.1
Description
Enrollment
Data type
string
Alias
- UMLS CUI
- C1516879
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Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
439401001 (SNOMED CT 2010_0731)
195110006 (SNOMED CT 2010_0731)
I50.0 (ICD-10 Version 2009)
422008005 (SNOMED CT 2010_0731)
139248000 (SNOMED CT 2010_0731)
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139201002 (SNOMED CT 2010_0731)
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10042244 (MedDRA 13.1)
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140075008 (SNOMED CT 2010_0731)
386534000 (SNOMED CT 2010_0731)
10003146 (MedDRA 13.1)
45007003 (SNOMED CT 2010_0731)
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