Systolic Heart Failure Disease length New York Heart Association Classification | Diastolic Heart Failure Disease length New York Heart Association Classification | Pharmaceutical Preparations Stable
Item
systolic or diastolic heart failure, diagnosed with either nyha functional class ii to iii at least 3 months prior to screening and on stable medication for at least 12 weeks.
boolean
C1135191 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C1135196 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Criteria Fulfill
Item
patients must have met either of the criteria at screening:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) greater than 20% but lower than 40% or
boolean
C0428772 (UMLS CUI [1])
Left ventricular ejection fraction | Amino-terminal pro-brain natriuretic peptide Unit of Measurement | Brain natriuretic peptide measurement
Item
patients with a documented lvef greater than 40% and with a history of nt-pro-bnp> 400pg/ml (or bnp > 100pg/ml) within 12 months of screening.
boolean
C0428772 (UMLS CUI [1])
C0754710 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
C1095989 (UMLS CUI [3])
Angiotensin II receptor antagonist | Aldosterone Receptor Antagonists | Diuretics | Exception Furosemide
Item
treatment with angiotensin receptor blockers (arbs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
boolean
C0521942 (UMLS CUI [1])
C1579268 (UMLS CUI [2])
C0012798 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0016860 (UMLS CUI [4,2])
Hypertrophic Cardiomyopathy
Item
hypertrophic cardiomyopathy (hcmp).
boolean
C0007194 (UMLS CUI [1])
Furosemide Dose Stable U/day
Item
if a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
boolean
C0016860 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Heart failure Stable | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonist | Decompensated cardiac failure
Item
stable heart failure requiring treatment with both an ace inhibitor and an arb or current acute decompensated heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0521942 (UMLS CUI [3,2])
C0581377 (UMLS CUI [4])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Secondary hypertension
Item
mean sitting systolic blood pressure ≥160 mmhg and/or mean sitting diastolic blood pressure ≥ 100mmhg and/or secondary forms of hypertension.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0155616 (UMLS CUI [3])
Sitting systolic blood pressure Persistent
Item
persistent sitting systolic blood pressure <90 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Angioedema
Item
history of angioedema.
boolean
C0002994 (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])