Body Weight
Item
body weight of ≤ 160 kg.
boolean
C0005910 (UMLS CUI [1])
Chronic heart failure Compensated New York Heart Association Classification | History Chronic heart failure
Item
subjects with compensated chf (nyha class ii - iii) at time of screening with a prior documented history of chronic heart failure.
boolean
C0264716 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
NT-proBNP
Item
nt-probnp >300 pg/ml (according to central measurement) at visit 1.
boolean
C1963813 (UMLS CUI [1])
Standard of Care Chronic heart failure
Item
subjects treated with appropriate and guideline-indicated chf standard of care.
boolean
C2936643 (UMLS CUI [1,1])
C0264716 (UMLS CUI [1,2])
Protocol Compliance
Item
ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
boolean
C0525058 (UMLS CUI [1])
Decompensated cardiac failure
Item
current acute decompensated hf
boolean
C0581377 (UMLS CUI [1])
Recipient Solid organ transplant Major | Organ Transplantation Anticipated Planned
Item
any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
boolean
C1709854 (UMLS CUI [1,1])
C0730400 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0029216 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Ventricular arrhythmia Syncopal Episode | Tachycardia, Ventricular | Ventricular Fibrillation | Implantable defibrillator Absent | Consequences Hemodynamic
Item
documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without icd (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
boolean
C0085612 (UMLS CUI [1,1])
C0751534 (UMLS CUI [1,2])
C0042514 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
C0162589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0686907 (UMLS CUI [5,1])
C0019010 (UMLS CUI [5,2])
Disease of mitral valve Hemodynamic Significant | Aortic valve disorder Hemodynamic Significant | Exception Mitral Valve Insufficiency Secondary to Left ventricular dilatation | Ventricular Outflow Obstruction, Left | Hypertrophic Cardiomyopathy | Aortic stenosis, severe
Item
presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
boolean
C0026265 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1260873 (UMLS CUI [2,1])
C0019010 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026266 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0344911 (UMLS CUI [3,4])
C0023213 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
C3806272 (UMLS CUI [6])
Renal Insufficiency Severe | GFR estimation by MDRD | Dialysis | Dialysis Planned | Ultrafiltration | Ultrafiltration Planned
Item
subjects with severe renal impairment defined as pre-randomization egfr < 30 ml/min/1.73m2 calculated using the smdrd equation and/or those receiving current or planned dialysis or ultrafiltration
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
C0011946 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0041612 (UMLS CUI [5])
C0041612 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])