Chronic heart failure New York Heart Association Classification
Item
patients with a diagnosis of chronic heart failure (nyha class ii - iv):
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Left ventricular ejection fraction CT scan | Left ventricular ejection fraction MRI | Left ventricular ejection fraction Ventricular angiography
Item
lvef ≤ 35% at visit 1. (local measurement, measured within the past 6 months assessed by echocardiogram, muga, ct scan, mri or ventricular angiography)
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5,1])
C1112786 (UMLS CUI [5,2])
Brain natriuretic peptide increased
Item
elevated bnp at visit 1: bnp ≥ 150 pg/ml (according to local measurement).
boolean
C1095988 (UMLS CUI [1])
Brain natriuretic peptide measurement | Hospitalization Due to Heart Failure Without Plan
Item
bnp ≥ 100 pg/ml (according to local measurement) and unplanned hospitalization with hf within the last 12 months prior visit 1.
boolean
C1095989 (UMLS CUI [1])
C3898876 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Enalapril U/day | Ramipril | quinapril | Lisinopril | Fosinopril | Perindopril | trandolapril
Item
patients must be treated with an ace inhibitor at a stable dose (enalapril 10 mg daily at least or any other ace inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of acei's) for at least 4 weeks prior to visit 1
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0014025 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0072973 (UMLS CUI [3])
C0072857 (UMLS CUI [4])
C0065374 (UMLS CUI [5])
C0118168 (UMLS CUI [6])
C0136123 (UMLS CUI [7])
C0076891 (UMLS CUI [8])
Hypersensitivity Investigational New Drugs | Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs | intolerance to Angiotensin-Converting Enzyme Inhibitors High dose
Item
history of hypersensitivity to any of the study drugs including history or allergy to acei's as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of acei's during up titration process.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0571939 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C1744706 (UMLS CUI [5,1])
C0003015 (UMLS CUI [5,2])
C0444956 (UMLS CUI [5,3])
Angiotensin II receptor antagonist | Aldosterone Antagonists | Investigational New Drugs
Item
patients treated concomitantly with both arb and aldosterone antagonist in addition to study drug at visit 1.
boolean
C0521942 (UMLS CUI [1])
C0002007 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Decompensated cardiac failure
Item
current acute decompensated hf.
boolean
C0581377 (UMLS CUI [1])
Hypotension symptomatic | Systolic Pressure
Item
symptomatic hypotension and/or less than 95 mmhg sbp at visit 1 and/or less than 90 mmhg at visit 4.
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Kidney Disease Life Threatening | Estimated Glomerular Filtration Rate Creatinine-based formula (MDRD) | Decreased glomerular filtration rate Percentage
Item
renal disease likely to be life threatening or egfr < 40 ml/min/1.73m2 as measured by the mdrd formula at visit 1 and egfr < 35 ml/min/1.73m2 as measured by the mdrd formula at visit 4 or decrease of egfr of more than 25% from visit 1 to visit 4 (according to local laboratory measurement).
boolean
C0022658 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C1980036 (UMLS CUI [2,2])
C0853068 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Serum potassium measurement
Item
serum potassium ≥ 5.0 mmol/l at visit 1 or ≥ 5.2 mmol/l at visit 4 (according to local laboratory measurement).
boolean
C0302353 (UMLS CUI [1])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Surgery procedures | Carotid surgery | Vascular Surgical Procedures Major | Percutaneous Coronary Intervention | Carotid angioplasty
Item
acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (pci) or carotid angioplasty, within the past 3 months prior to visit 1.
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C0741984 (UMLS CUI [5])
C0042381 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C1532338 (UMLS CUI [7])
C3203476 (UMLS CUI [8])
Coronary Artery Disease Requirement Operative Surgical Procedures | Carotid Artery Disease Requirement Operative Surgical Procedures | Coronary Artery Disease Requirement Intervention Percutaneous | Carotid Artery Disease Requirement Intervention Percutaneous
Item
coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after visit 1.
boolean
C1956346 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0007273 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
C0522523 (UMLS CUI [3,4])
C0007273 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
C0522523 (UMLS CUI [4,4])
Right Heart Failure Due to Lung disease Severe
Item
right heart failure due to severe pulmonary disease
boolean
C0235527 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0024115 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])