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