Reduced ejection fraction Symptomatic | Heart failure Etiology Ischemic | Heart failure Etiology Dilated Cardiomyopathy
Item
must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
boolean
C4022792 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0475224 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0007193 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification
Item
must have heart failure classified by the new york heart association classification system as class i through iiia
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of < = 45%
boolean
C0428772 (UMLS CUI [1])
beta1-adrenergic receptor Autoantibodies Increased
Item
must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
boolean
C1152727 (UMLS CUI [1,1])
C0004358 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
Therapy Heart failure | Drug dose Stable
Item
must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0678766 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Illness Study Subject Participation Status Unfavorable | Illness compromises Well Being | Illness Interferes with Evaluation
Item
history of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C3813622 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
Left ventricle end diastolic Diameter Index
Item
left ventricular end-diastolic diameter index (a measure of the heart's performance) of <= 32 mm/m2
boolean
C0225897 (UMLS CUI [1,1])
C0442709 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0918012 (UMLS CUI [1,4])
N-Terminal ProB-type Natriuretic Peptide Measurement | Normal sinus rhythm | Atrial Fibrillation
Item
n-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is <= 200 pg/ml in participants with normal sinus rhythm or <= 800 pg/ml in participants with atrial fibrillation
boolean
C3272900 (UMLS CUI [1])
C0232202 (UMLS CUI [2])
C0004238 (UMLS CUI [3])
Immunosuppressive Agents chronic | Exception Prednisone Equivalent U/day
Item
chronic treatment with immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Hypersensitivity Peptides | Protein allergy | Hypersensitivity Albumin
Item
known allergies to peptides or proteins, such as albumin.
boolean
C0020517 (UMLS CUI [1,1])
C0030956 (UMLS CUI [1,2])
C1112677 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0001924 (UMLS CUI [3,2])