Informed Consent
Item
patients must give written informed consent before any assessment is performed.
boolean
C0021430 (UMLS CUI [1])
Outpatients | Age
Item
outpatients ≥ 18 years of age, male or female.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic heart failure New York Heart Association Classification | Reduced ejection fraction | Cardiac ejection fraction | Brain natriuretic peptide increased
Item
patients with a diagnosis of chf nyha class ii-iv and reduced ejection fraction (ef =< 35%) and elevated bnp.
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C4022792 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
C1095988 (UMLS CUI [4])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Enalapril Dose | Equivalent
Item
patients must be on an acei or an arb at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0014025 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4])
Adrenergic beta-Antagonist Dose Stable | Exception Medical contraindication | Exception Intolerance to substance
Item
patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
boolean
C0001645 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1744706 (UMLS CUI [3,2])
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Angiotensin-converting-enzyme inhibitor allergy | Allergy to angiotensin II receptor antagonist | Hypersensitivity NEP inhibitors | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs
Item
history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0571939 (UMLS CUI [3])
C2585204 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0025250 (UMLS CUI [5,2])
C0243077 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0013230 (UMLS CUI [7,3])
Intolerance to Angiotensin-Converting Enzyme Inhibitors Dose | Intolerance to Angiotensin II receptor antagonist Dose
Item
previous history of intolerance to recommended target doses of aceis or arbs
boolean
C1744706 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Angioedema
Item
known history of angioedema.
boolean
C0002994 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors Therapy Required | Angiotensin II receptor antagonist Therapy Required
Item
requirement of treatment with both aceis and arbs.
boolean
C0003015 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Decompensated cardiac failure | Exacerbation Chronic heart failure | Signs and Symptoms Requirement Intravenous therapy
Item
current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy).
boolean
C0581377 (UMLS CUI [1])
C4086268 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
C0037088 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0455142 (UMLS CUI [3,3])
Hypotension symptomatic | Systolic Pressure
Item
symptomatic hypotension and/or a sbp < 100 mmhg.
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
GFR estimation by MDRD
Item
estimated gfr < 30 ml/min/1.73m2 as measured by the simplified mdrd formula
boolean
C2170215 (UMLS CUI [1])
Serum potassium measurement
Item
serum potassium > 5.2 mmol/l.
boolean
C0302353 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])