Gender | Age | Postmenopausal state | Gender Childbearing Potential Absent | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy
Item
men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0015787 (UMLS CUI [5])
C0589114 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0020699 (UMLS CUI [8])
Chronic heart failure Ischemic New York Heart Association Classification | Chronic heart failure New York Heart Association Classification | Evidence based treatment Chronic heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Diuretics | Exception Medical contraindication | Exception Intolerance
Item
clinical diagnosis of chf (chronic heart failure), either ischemic or non-ischemic, nyha (new york heart association) class ii - iii, treated with evidenced-based therapy for chf, e.g. beta-blockers and ace (angiotensin-converting enzyme) inhibitors or arb (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
boolean
C0264716 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1740791 (UMLS CUI [3,1])
C0264716 (UMLS CUI [3,2])
C0304516 (UMLS CUI [4])
C0003015 (UMLS CUI [5])
C0521942 (UMLS CUI [6])
C0012798 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1301624 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C1744706 (UMLS CUI [9,2])
Kidney damage Duration | Structural renal abnormalities | Abnormal renal function
Item
known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
boolean
C1408258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4012846 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Part Upper case Roman letter | GFR estimation by MDRD
Item
part a: 60 ml/min/1.73 m2 </= egfr (estimated glomerular filtration rate) < 90 ml/min/1.73 m2 (mdrd, modification of diet in renal disease) at the screening visit
boolean
C0449719 (UMLS CUI [1,1])
C0439103 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Part Upper case Roman letter | GFR estimation by MDRD
Item
part b: 30 ml/min/1.73 m2 </= egfr <= 60 ml/min/1.73 m2 (mdrd) at the screening visit
boolean
C0449719 (UMLS CUI [1,1])
C0439103 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Serum potassium measurement
Item
serum potassium </= 4.8 mmol/l at the screening visit
boolean
C0302353 (UMLS CUI [1])
Systolic Pressure | Absence Sign or Symptom Hypotension
Item
systolic blood pressure >/= 90 mmhg without signs or symptoms of hypotension at the screening visit
boolean
C0871470 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0020649 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Spironolactone allergy | Hypersensitivity Spironolactone Excipient
Item
known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (part b only)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0571912 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0037982 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Anuria | Kidney Failure | Addison Disease
Item
subjects with anuria, acute renal failure, or addison's disease
boolean
C0003460 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
Acute Coronary Syndrome | Coronary Artery Disease Unstable
Item
acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
boolean
C0948089 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Heart valve disease | Requirement Surgical intervention
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
Hospitalization Hyperkalemia | Hospitalization Kidney Failure | Etiology Aldosterone Antagonists
Item
history of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
boolean
C0019993 (UMLS CUI [1,1])
C0020461 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0002007 (UMLS CUI [3,2])