ID
5510
Beskrivning
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
Nyckelord
Versioner (3)
- 2013-12-11 2013-12-11 - Martin Dugas
- 2014-08-07 2014-08-07 - Martin Dugas
- 2015-08-27 2015-08-27 - Martin Dugas
Uppladdad den
7 augusti 2014
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00071331 Heart Failure
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
Reproductive precautions
Datatyp
boolean
Beskrivning
Pregnant
Datatyp
boolean
Beskrivning
Inability for consent
Datatyp
boolean
Beskrivning
Cardiac surgery
Datatyp
boolean
Beskrivning
Planned cardiac procedures
Datatyp
boolean
Beskrivning
Cardiac mechanical support
Datatyp
boolean
Beskrivning
Bi-ventricular pacer
Datatyp
boolean
Beskrivning
Life expectancy
Datatyp
boolean
Beskrivning
Myocardial infarction
Datatyp
boolean
Beskrivning
Ventricular arrhythmia
Datatyp
boolean
Beskrivning
Stroke
Datatyp
boolean
Beskrivning
Cardiac valvular disease
Datatyp
boolean
Beskrivning
Hypertrophic cardiomyopathy
Datatyp
boolean
Beskrivning
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Datatyp
boolean
Beskrivning
Multiple sclerosis, Stroke
Datatyp
boolean
Beskrivning
Liver disease
Datatyp
boolean
Beskrivning
Diabetes mellitus
Datatyp
boolean
Beskrivning
Obesity
Datatyp
boolean
Beskrivning
Systolic blood pressure
Datatyp
boolean
Beskrivning
Serum creatinine
Datatyp
boolean
Beskrivning
Serum potassium
Datatyp
boolean
Beskrivning
Hemoglobin
Datatyp
boolean
Beskrivning
Hypersensitivity to benzazepine
Datatyp
boolean
Beskrivning
Drug or alcohol abuse
Datatyp
boolean
Beskrivning
Inability to take oral medications
Datatyp
boolean
Beskrivning
Other trial
Datatyp
boolean
Beskrivning
Other tolvaptan trial
Datatyp
boolean
Beskrivning
Medizinische Konzepte
Beskrivning
Age
Datatyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beskrivning
Diagnosis
Datatyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beskrivning
Chronic congestive heart failure
Datatyp
string
Alias
- UMLS CUI
- C0264722
- SNOMED CT 2010_0731
- 195110006
- ICD-10 Version 2009
- I50.0
Beskrivning
Jugular venous distention
Datatyp
string
Alias
- UMLS CUI
- C1719935
- SNOMED CT 2010_0731
- 422008005
Beskrivning
Pitting edema
Datatyp
string
Alias
- UMLS CUI
- C0333243
- SNOMED CT 2010_0731
- 139248000
- MedDRA 13.1
- 10054547
Beskrivning
Dyspnea
Datatyp
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
Beskrivning
New York Heart Association Classification
Datatyp
string
Alias
- UMLS CUI
- C1275491
- SNOMED CT 2010_0731
- 420816009
Beskrivning
Cardiac ejection fraction
Datatyp
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Beskrivning
pregnant
Datatyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beskrivning
Therapeutic procedure
Datatyp
string
Alias
- UMLS CUI
- C0087111
Beskrivning
Life expectancy
Datatyp
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Beskrivning
Acute myocardial infarction
Datatyp
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
Beskrivning
Ventricular arrhythmia
Datatyp
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
Beskrivning
Stroke
Datatyp
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
Beskrivning
Hypertrophic cardiomyopathy
Datatyp
string
Alias
- UMLS CUI
- C0007194
- SNOMED CT 2010_0731
- 233873004
- MedDRA 13.1
- 10020871
Beskrivning
Weight
Datatyp
string
Alias
- UMLS
- C0005910
- LOINC Version 232
- LP18015-5
- MedDRA 13.1
- 10047890
- SNOMED CT 2010_0731
- 107647005
Beskrivning
BMI
Datatyp
string
Alias
- UMLS CUI
- C1305855
- LOINC Version 232
- LP35925-4
- MedDRA 13.1
- 10005894
- SNOMED CT 2010_0731
- 140075008
Beskrivning
Arterial blood pressure
Datatyp
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Beskrivning
Low blood pressure
Datatyp
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
Beskrivning
Creatinine
Datatyp
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Beskrivning
Potassium
Datatyp
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Beskrivning
Hemoglobin
Datatyp
string
Alias
- SNOMED CT 2010_0731
- 38082009
- UMLS CUI
- C0019046
- MedDRA 13.1
- 10019481
- LOINC
- LP14449-0
Beskrivning
Allergic reaction, due to correct medicinal substance properly administered
Datatyp
string
Alias
- UMLS CUI
- C0274302
- SNOMED CT 2010_0731
- 57302007
Beskrivning
Drug abuse
Datatyp
string
Alias
- UMLS CUI
- C0013146
- SNOMED CT 2010_0731
- 26416006
- MedDRA 13.1
- 10013654
- LOINC
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
Beskrivning
Alcohol abuse
Datatyp
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
Beskrivning
Enrollment
Datatyp
string
Alias
- UMLS CUI
- C1516879
Similar models
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)
10054547 (MedDRA 13.1)
139201002 (SNOMED CT 2010_0731)
10013963 (MedDRA 13.1)
R06.0 (ICD-10-CM Version 2010)
E13368 (CTCAE Version 4.03)
420816009 (SNOMED CT 2010_0731)
70822001 (SNOMED CT 2010_0731)
10036586 (MedDRA 13.1)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10 Version 2009)
410 (ICD-9-CM Version 2011)
44103008 (SNOMED CT 2010_0731)
10047281 (MedDRA 13.1)
I47.2 (ICD-10 Version 2009)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE Version 4.03)
230690007 (SNOMED CT 2010_0731)
10042244 (MedDRA 13.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE Version 4.03)
233873004 (SNOMED CT 2010_0731)
10020871 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
10047890 (MedDRA 13.1)
107647005 (SNOMED CT 2010_0731)
LP35925-4 (LOINC Version 232)
10005894 (MedDRA 13.1)
140075008 (SNOMED CT 2010_0731)
386534000 (SNOMED CT 2010_0731)
10003146 (MedDRA 13.1)
45007003 (SNOMED CT 2010_0731)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)
57302007 (SNOMED CT 2010_0731)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC)
305.90 (ICD-9-CM Version 2011)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC)
305.0 (ICD-9-CM Version 2011)
F10.1 (ICD-10-CM Version 2010)