Heart failure Symptomatic Disease length
Item
must have symptomatic heart failure for at least 3 months prior to screening
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Episode of Decompensated cardiac failure | Requirement Hospital Stay Overnight | Medication administration: intravenous | Heart failure Patient observation | Parenteral therapy Heart failure Stabilization | Symptoms Dyspnea Worsening | Symptoms Fatigue | Signs Congestion | Peripheral edema | Ascites | Adjustment Heart failure Pharmaceutical Preparations
Item
participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. an episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
boolean
C0332189 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3489408 (UMLS CUI [2,2])
C0439583 (UMLS CUI [2,3])
C0812149 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0700325 (UMLS CUI [4,2])
C0259961 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C1293130 (UMLS CUI [5,3])
C1457887 (UMLS CUI [6,1])
C0013404 (UMLS CUI [6,2])
C0332271 (UMLS CUI [6,3])
C1457887 (UMLS CUI [7,1])
C0015672 (UMLS CUI [7,2])
C0311392 (UMLS CUI [8,1])
C0700148 (UMLS CUI [8,2])
C0085649 (UMLS CUI [9])
C0003962 (UMLS CUI [10])
C0456081 (UMLS CUI [11,1])
C0018801 (UMLS CUI [11,2])
C0013227 (UMLS CUI [11,3])
Left ventricular ejection fraction
Item
must have a documented left ventricular ejection fraction (lvef) of less than or equal to 40 percent (%) within 1 year before randomization
boolean
C0428772 (UMLS CUI [1])
Coronary Artery Disease
Item
must have evidence of significant coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Stable status Medical | Heart failure Clinical status
Item
must be medically stable in terms of their heart failure clinical status at the time of randomization
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0449440 (UMLS CUI [2,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
must have a brain natriuretic peptide (bnp) level greater than or equal to (>=) 200 picogram per milliliter (pg/ml) or n-terminal-probnp (nt-probnp) level >=800 pg/ml (preferred assay) during the screening period and before randomization
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Medical contraindication Anticoagulant therapy | Condition Associated with Bleeding risk | Internal hemorrhage | Hemorrhage Clinical Significance | Bleeding tendency
Item
any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
C1390214 (UMLS CUI [3])
C0019080 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C1458140 (UMLS CUI [5])
Comorbidity Severe | Atrial Fibrillation | Condition Requirement Chronic anticoagulation | Myocardial Infarction
Item
severe concomitant disease such as (a) atrial fibrillation (afib) or another condition that requires chronic anticoagulation (participants with isolated transient afib may be allowed at the discretion of the treating physician investigator) and (b) documented acute myocardial infarction (mi) during index event
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0694554 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
Cerebrovascular accident
Item
prior stroke within 90 days of randomization
boolean
C0038454 (UMLS CUI [1])
Hospitalization Duration
Item
has been hospitalized for longer than 21 days during the index event
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Inotropic agent Intravenous Planned
Item
planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])