Age
Item
Age greater than or equal to 18 years
boolean
Chronic congestive heart failure
Item
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
boolean
NYHA III - IV
Item
NYHA Class III or IV at the time of hospitalization
boolean
Ejection Fraction
Item
Left Ventricular Ejection Fraction <= 40% within one year
boolean
Reproductive precautions
Item
Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form
boolean
Pregnant
Item
Positive urine pregnancy test
boolean
Inability for consent
Item
Inability to provide written informed consent
boolean
Cardiac surgery
Item
Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions
boolean
Planned cardiac procedures
Item
Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment
boolean
Cardiac mechanical support
Item
Subjects who are on cardiac mechanical support
boolean
Bi-ventricular pacer
Item
History of bi-ventricular pacer placement within the last 60 days
boolean
Life expectancy
Item
Co-morbid condition with an expected survival less than six months
boolean
Myocardial infarction
Item
Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization
boolean
Ventricular arrhythmia
Item
History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator
boolean
Stroke
Item
History of a cerebrovascular accident within the last 30 days
boolean
Cardiac valvular disease
Item
Hemodynamically significant uncorrected primary cardiac valvular disease
boolean
Hypertrophic cardiomyopathy
Item
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
boolean
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Item
CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
boolean
Multiple sclerosis, Stroke
Item
Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes
boolean
Liver disease
Item
History of primary significant liver disease or acute hepatic failure, as defined by the investigator
boolean
Diabetes mellitus
Item
History of poorly controlled diabetes mellitus
boolean
Obesity
Item
Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40
boolean
Systolic blood pressure
Item
Supine systolic arterial blood pressure < 90 mmHg
boolean
Serum creatinine
Item
Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L
boolean
Serum potassium
Item
Serum potassium > 5.5 mEq/L or > 5.5 mmol/L
boolean
Hemoglobin
Item
Hemoglobin < 9 g/dL or < 90 g/L
boolean
Hypersensitivity to benzazepine
Item
History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril)
boolean
Drug or alcohol abuse
Item
History of drug or medication abuse within the past year, or current alcohol abuse
boolean
Inability to take oral medications
Item
Inability to take oral medications
boolean
Other trial
Item
Participation in another clinical drug or device trial within the past 30 days
boolean
Other tolvaptan trial
Item
Previous participation in this or any other tolvaptan clinical trial
boolean
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Chronic congestive heart failure
Item
Chronic congestive heart failure
string
C0264722 (UMLS CUI)
195110006 (SNOMED CT 2010_0731)
I50.0 (ICD-10 Version 2009)
Jugular venous distention
Item
Characteristic of jugular venous distention
string
C1719935 (UMLS CUI)
422008005 (SNOMED CT 2010_0731)
Pitting edema
Item
Pitting edema
string
C0333243 (UMLS CUI)
139248000 (SNOMED CT 2010_0731)
10054547 (MedDRA 13.1)
Dyspnea
Item
Dyspnea
string
C0013404 (UMLS CUI)
139201002 (SNOMED CT 2010_0731)
10013963 (MedDRA 13.1)
R06.0 (ICD-10-CM Version 2010)
E13368 (CTCAE Version 4.03)
New York Heart Association Classification
Item
NYHA class
string
C1275491 (UMLS CUI)
420816009 (SNOMED CT 2010_0731)
Cardiac ejection fraction
Item
Ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10 Version 2009)
410 (ICD-9-CM Version 2011)
Ventricular arrhythmia
Item
Ventricular arrhythmia
string
C0085612 (UMLS CUI)
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)
Stroke
Item
Cerebrovascular accident
string
C0038454 (UMLS CUI)
230690007 (SNOMED CT 2010_0731)
10042244 (MedDRA 13.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE Version 4.03)
Hypertrophic cardiomyopathy
Item
Hypertrophic cardiomyopathy
string
C0007194 (UMLS CUI)
233873004 (SNOMED CT 2010_0731)
10020871 (MedDRA 13.1)
Weight
Item
Weight
string
C0005910 (UMLS)
LP18015-5 (LOINC Version 232)
10047890 (MedDRA 13.1)
107647005 (SNOMED CT 2010_0731)
BMI
Item
Body mass index
string
C1305855 (UMLS CUI)
LP35925-4 (LOINC Version 232)
10005894 (MedDRA 13.1)
140075008 (SNOMED CT 2010_0731)
Arterial blood pressure
Item
Arterial blood pressure
string
C1272641 (UMLS CUI)
386534000 (SNOMED CT 2010_0731)
Low blood pressure
Item
Arterial blood pressure decreased
string
C0020649 (UMLS CUI)
10003146 (MedDRA 13.1)
45007003 (SNOMED CT 2010_0731)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)
Creatinine
Item
Serum Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Potassium
Item
Serum Potassium
string
C0202194 (UMLS CUI)
88480006 (SNOMED CT 2010_0731)
2823-3 (LOINC)
10036439 (MedDRA 13.1)
Hemoglobin
Item
Hemoglobin
string
38082009 (SNOMED CT 2010_0731)
C0019046 (UMLS CUI)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC)
Allergic reaction, due to correct medicinal substance properly administered
Item
Hypersensitivity to medication
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC)
305.90 (ICD-9-CM Version 2011)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
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)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)