Age | Heart failure New York Heart Association Classification
Item
male or female ≥18 years of age diagnosed with nyha class iii or iv heart failure in the last six months
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization
Item
female patients must be post-menopausal or surgically sterile
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Heart failure | Left ventricular ejection fraction | Volume overload Sign or Symptom Quantity
Item
diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0546817 (UMLS CUI [3,1])
C3540840 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
women who are pregnant, breast-feeding or of child-bearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Patients Unstable Clinical
Item
clinically unstable patients
boolean
C0030705 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Major surgery
Item
major surgical procedures within 30 days of entry
boolean
C0679637 (UMLS CUI [1])
Temperature febrile Degrees fahrenheit
Item
febrile temp > 100 degrees f)
boolean
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0456628 (UMLS CUI [1,3])
Carotid disease Symptomatic | Carotid Stenosis Critical | Cerebrovascular accident
Item
symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
boolean
C0741975 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007282 (UMLS CUI [2,1])
C1511545 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
Vasoactive agent Intravenous | Heart Transplantation Scheduled
Item
currently on iv vasoactive support (e.g., heart transplant candidate)
boolean
C0597639 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Syncope Unknown
Item
history of unexplained syncope within the past 3 months
boolean
C0039070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Comorbidity | Heart valve stenosis | Aortic valve disorder | Restrictive cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Pericarditis, Constrictive | Primary pulmonary hypertension | Disease Infiltrating | Congenital heart disease uncorrected | Acute Coronary Syndrome | Restrictive heart failure | Condition Study Subject Participation Status Excluded
Item
comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the investigator, would prevent a patient's participation in the study.
boolean
C0009488 (UMLS CUI [1])
C0264878 (UMLS CUI [2])
C1260873 (UMLS CUI [3])
C0007196 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
C0031048 (UMLS CUI [6])
C0152171 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C0332448 (UMLS CUI [8,2])
C0152021 (UMLS CUI [9,1])
C4072785 (UMLS CUI [9,2])
C0948089 (UMLS CUI [10])
C1832374 (UMLS CUI [11])
C0348080 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C2828389 (UMLS CUI [12,3])
Study Subject Participation Status | Therapies, Investigational | Investigational Medical Device
Item
participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Nesiritide
Item
treatment with nesiritide within 14 days prior to dosing.
boolean
C0054015 (UMLS CUI [1])
Lacking Able to communicate Study Personnel
Item
inability to effectively communicate with study personnel.
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C2985653 (UMLS CUI [1,3])