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