ID
5510
Beschrijving
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
Trefwoorden
Versies (3)
- 11-12-13 11-12-13 - Martin Dugas
- 07-08-14 07-08-14 - Martin Dugas
- 27-08-15 27-08-15 - Martin Dugas
Geüploaded op
7 augustus 2014
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00071331 Heart Failure
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Beschrijving
Reproductive precautions
Datatype
boolean
Beschrijving
Pregnant
Datatype
boolean
Beschrijving
Inability for consent
Datatype
boolean
Beschrijving
Cardiac surgery
Datatype
boolean
Beschrijving
Planned cardiac procedures
Datatype
boolean
Beschrijving
Cardiac mechanical support
Datatype
boolean
Beschrijving
Bi-ventricular pacer
Datatype
boolean
Beschrijving
Life expectancy
Datatype
boolean
Beschrijving
Myocardial infarction
Datatype
boolean
Beschrijving
Ventricular arrhythmia
Datatype
boolean
Beschrijving
Stroke
Datatype
boolean
Beschrijving
Cardiac valvular disease
Datatype
boolean
Beschrijving
Hypertrophic cardiomyopathy
Datatype
boolean
Beschrijving
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Datatype
boolean
Beschrijving
Multiple sclerosis, Stroke
Datatype
boolean
Beschrijving
Liver disease
Datatype
boolean
Beschrijving
Diabetes mellitus
Datatype
boolean
Beschrijving
Obesity
Datatype
boolean
Beschrijving
Systolic blood pressure
Datatype
boolean
Beschrijving
Serum creatinine
Datatype
boolean
Beschrijving
Serum potassium
Datatype
boolean
Beschrijving
Hemoglobin
Datatype
boolean
Beschrijving
Hypersensitivity to benzazepine
Datatype
boolean
Beschrijving
Drug or alcohol abuse
Datatype
boolean
Beschrijving
Inability to take oral medications
Datatype
boolean
Beschrijving
Other trial
Datatype
boolean
Beschrijving
Other tolvaptan trial
Datatype
boolean
Beschrijving
Medizinische Konzepte
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschrijving
Diagnosis
Datatype
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschrijving
Chronic congestive heart failure
Datatype
string
Alias
- UMLS CUI
- C0264722
- SNOMED CT 2010_0731
- 195110006
- ICD-10 Version 2009
- I50.0
Beschrijving
Jugular venous distention
Datatype
string
Alias
- UMLS CUI
- C1719935
- SNOMED CT 2010_0731
- 422008005
Beschrijving
Pitting edema
Datatype
string
Alias
- UMLS CUI
- C0333243
- SNOMED CT 2010_0731
- 139248000
- MedDRA 13.1
- 10054547
Beschrijving
Dyspnea
Datatype
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
Beschrijving
New York Heart Association Classification
Datatype
string
Alias
- UMLS CUI
- C1275491
- SNOMED CT 2010_0731
- 420816009
Beschrijving
Cardiac ejection fraction
Datatype
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Beschrijving
pregnant
Datatype
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschrijving
Therapeutic procedure
Datatype
string
Alias
- UMLS CUI
- C0087111
Beschrijving
Life expectancy
Datatype
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Beschrijving
Acute myocardial infarction
Datatype
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
Beschrijving
Ventricular arrhythmia
Datatype
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
Beschrijving
Stroke
Datatype
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
Beschrijving
Hypertrophic cardiomyopathy
Datatype
string
Alias
- UMLS CUI
- C0007194
- SNOMED CT 2010_0731
- 233873004
- MedDRA 13.1
- 10020871
Beschrijving
Weight
Datatype
string
Alias
- UMLS
- C0005910
- LOINC Version 232
- LP18015-5
- MedDRA 13.1
- 10047890
- SNOMED CT 2010_0731
- 107647005
Beschrijving
BMI
Datatype
string
Alias
- UMLS CUI
- C1305855
- LOINC Version 232
- LP35925-4
- MedDRA 13.1
- 10005894
- SNOMED CT 2010_0731
- 140075008
Beschrijving
Arterial blood pressure
Datatype
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Beschrijving
Low blood pressure
Datatype
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
Beschrijving
Creatinine
Datatype
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Beschrijving
Potassium
Datatype
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Beschrijving
Hemoglobin
Datatype
string
Alias
- SNOMED CT 2010_0731
- 38082009
- UMLS CUI
- C0019046
- MedDRA 13.1
- 10019481
- LOINC
- LP14449-0
Beschrijving
Allergic reaction, due to correct medicinal substance properly administered
Datatype
string
Alias
- UMLS CUI
- C0274302
- SNOMED CT 2010_0731
- 57302007
Beschrijving
Drug abuse
Datatype
string
Alias
- UMLS CUI
- C0013146
- SNOMED CT 2010_0731
- 26416006
- MedDRA 13.1
- 10013654
- LOINC
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
Beschrijving
Alcohol abuse
Datatype
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
Beschrijving
Enrollment
Datatype
string
Alias
- UMLS CUI
- C1516879
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