Hospitalization Qualifying Quantity | Hospitalization Equivalent Qualifying Quantity | Patient Discharge
Item
had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
boolean
C0019993 (UMLS CUI [1,1])
C1514624 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C1514624 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0030685 (UMLS CUI [3])
New York Heart Association Classification
Item
have documentation indicating that the patient was consistently new york heart association (nyha) class iii or iv during the 60 days before randomization
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
have a left ventricular ejection fraction less than 40% (measured within 24 weeks before randomization)
boolean
C0428772 (UMLS CUI [1])
New York Heart Association Class IV | New York Heart Association Class III | Creatinine clearance measurement
Item
are (1)nyha class iv or (2)nyha class iii with highest calculated crcl, 60ml/min within the previous 30 days
boolean
C1882087 (UMLS CUI [1])
C1882086 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
oral medication Long-term | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Medical contraindication oral medication | intolerance to oral medication
Item
are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ace) inhibitors, angiotensin ii receptor blockers (arbs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
boolean
C0175795 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0175795 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0175795 (UMLS CUI [7,2])
Protocol Compliance | Investigational New Drugs Infusion | Clinical Study Follow-up
Item
agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. in addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed
boolean
C0525058 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3])
Systolic Pressure
Item
have systolic blood pressure consistently <90mm hg
boolean
C0871470 (UMLS CUI [1])
Infusion Discontinue Unable | Dopamine | Dobutamine | Milrinone | Nitroglycerin | Nesiritide
Item
are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label natrecor beginning at the time of the screening visit
boolean
C0574032 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013030 (UMLS CUI [2])
C0012963 (UMLS CUI [3])
C0128513 (UMLS CUI [4])
C0017887 (UMLS CUI [5])
C0054015 (UMLS CUI [6])
Infusion care Vasoactive | Milrinone | Dobutamine | Dopamine | Nitroglycerin | Nesiritide | Outpatient Infusion Therapy Quantity | Hospitalization
Item
have required recent outpatient iv vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
boolean
C2958553 (UMLS CUI [1,1])
C1980011 (UMLS CUI [1,2])
C0128513 (UMLS CUI [2])
C0012963 (UMLS CUI [3])
C0013030 (UMLS CUI [4])
C0017887 (UMLS CUI [5])
C0054015 (UMLS CUI [6])
C0242944 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0019993 (UMLS CUI [8])
Organ Transplantation | Heart Transplantation | Transplantation of liver | Lung Transplantation | Kidney Transplantation | Bone Marrow Transplantation
Item
had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
boolean
C0029216 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0024128 (UMLS CUI [4])
C0022671 (UMLS CUI [5])
C0005961 (UMLS CUI [6])
Biventricular Pacemaker Implantation | Single Chamber Pacemaker Implantation | Dual Chamber Pacemaker Implantation | Implantation of automatic cardiac defibrillator
Item
had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
boolean
C1719274 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C2911682 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
C2911683 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
C0397417 (UMLS CUI [4])
medical condition Contraindication Nesiritide | Shock, Cardiogenic | Hypovolemia
Item
have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of natrecor
boolean
C3843040 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0054015 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
C0546884 (UMLS CUI [3])
Dialysis chronic | Dialysis Expected
Item
are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months.
boolean
C0011946 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])