ID

40840

Description

Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate; ODM derived from: https://clinicaltrials.gov/show/NCT01109043

Link

https://clinicaltrials.gov/show/NCT01109043

Keywords

  1. 5/23/20 5/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 23, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypertension NCT01109043

Eligibility Hypertension NCT01109043

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with high blood pressure (bp) and tachycardia
Description

Hypertensive disease | Tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0039231
subjects with essential hypotonia, angina pectoris
Description

Hypotension Essential | Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0205224
UMLS CUI [2]
C0002962
subjects with essential hypertonia, when a therapy with ß-blockers or diuretics is not sufficiently effective
Description

Essential Hypertension | Adrenergic beta-1 Receptor Antagonists ineffective | Diuretics ineffective

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C3242229
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C3242229
precautions to be taken in case of severe peripheral circulation disorders, diabetes (especially at the time, when blood sugar is elevated), during a strict fast, in case of metabolic acidosis, atrioventricular block (av) block of grade i, prinzmetal angina, additional therapy with angiotensin-converting enzyme inhibitors (ace-inhibitors), severe coronary or cerebral sclerosis, hyperuricemia or gout and in subjects with a history of severe hypersensitive reactions or during a desensitization therapy (excessive anaphylactic reaction, attenuated adrenergic counterregulation)
Description

Precautions | Poor peripheral circulation | Diabetes Mellitus | Metabolic acidosis | First degree atrioventricular block | Angina Pectoris, Variant | Angiotensin-Converting Enzyme Inhibitors | Coronary Arteriosclerosis Severe | Tuberous Sclerosis Severe | Hyperuricemia | Gout | Allergic Reaction Severe | Hypersensitivity desensitization | Anaphylaxis Excessive | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C1882442
UMLS CUI [2]
C0520547
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0220981
UMLS CUI [5]
C0085614
UMLS CUI [6]
C0002963
UMLS CUI [7]
C0003015
UMLS CUI [8,1]
C0010054
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0041341
UMLS CUI [9,2]
C0205082
UMLS CUI [10]
C0740394
UMLS CUI [11]
C0018099
UMLS CUI [12,1]
C1527304
UMLS CUI [12,2]
C0205082
UMLS CUI [13]
C0178702
UMLS CUI [14,1]
C0002792
UMLS CUI [14,2]
C0442802
UMLS CUI [15]
C3846158
special precautions must be taken with the subjects that have a family history or suffered from psoriasis, during a desensitization therapy (also anamnestic subjects), other obstructive pulmonary diseases on account of the possibility of initiation or intensification of bronchoconstriction, although, due to the marked ß1-selectivity of bisoprolol, the risk is lower than with non-selective ß-receptor blockers. the subjects that have a family history or suffered from psoriasis should the take concor plus only after a careful assessment of risk - benefit ratio. the subjects with pheochromocytoma should take concor plus, as well as other ß-blockers after inhibiting the alpha-receptors
Description

Precautions Special | Family history Psoriasis | Psoriasis | Lung Diseases, Obstructive | Bronchoconstriction | Adrenergic beta-1 Receptor Antagonists | Concor | Pheochromocytoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1882442
UMLS CUI [1,2]
C0205555
UMLS CUI [2]
C0455439
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0600260
UMLS CUI [5]
C0079043
UMLS CUI [6]
C0304516
UMLS CUI [7]
C0110591
UMLS CUI [8]
C0031511
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with acute cardiac insufficiency, sinus sick syndrome, bradycardia and anaemia
Description

Heart failure | Sick Sinus Syndrome | Bradycardia | Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0037052
UMLS CUI [3]
C0428977
UMLS CUI [4]
C0002871
contraindicated medical conditions for bisoprolol as defined in the product information, i.e. a known hypersensitivity to the active agent bisoprolol or one of the inactive ingredients of the medication; acute heart failure or decompensation of heart insufficiency, that requires a therapy with inotropic agents; cardiogenic shock; av block grade ii or iii (in the absence of cardiac pacemakers); sick sinus syndrome, sinoatrial heart block; symptomatic bradycardia; symptomatic hypotonia; severe asthma bronchiolus or severe chronic obstructive airways disease; advanced stages of peripheral arterial disease or raynaud's syndrome; untreated pheochromocytoma, metabolic acidosis
Description

Medical condition Contraindicated Bisoprolol | Hypersensitivity Bisoprolol | Hypersensitivity Inactive ingredient Medication | Heart failure | Decompensated cardiac failure | Requirement Inotropic agent | Shock, Cardiogenic | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent | Sick Sinus Syndrome | Sinoatrial Block | BRADYCARDIA SYMPTOMATIC | Hypotension symptomatic | Severe asthma | Severe chronic obstructive pulmonary disease | Peripheral Arterial Disease Advanced | Raynaud Disease | Pheochromocytoma Untreated | Metabolic acidosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0053799
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0053799
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1552019
UMLS CUI [3,3]
C0013227
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0581377
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0304509
UMLS CUI [7]
C0036980
UMLS CUI [8]
C0264906
UMLS CUI [9]
C0151517
UMLS CUI [10,1]
C0030163
UMLS CUI [10,2]
C0332197
UMLS CUI [11]
C0037052
UMLS CUI [12]
C0037188
UMLS CUI [13]
C0741627
UMLS CUI [14]
C0863113
UMLS CUI [15]
C0581126
UMLS CUI [16]
C0730607
UMLS CUI [17,1]
C1704436
UMLS CUI [17,2]
C0205179
UMLS CUI [18]
C0034734
UMLS CUI [19,1]
C0031511
UMLS CUI [19,2]
C0332155
UMLS CUI [20]
C0220981
contraindicated medical conditions for bisoprolol + hydrochlorothiazide (hctz) as defined in the product information, i.e. hypersensitivity to the ingredients of the medication containing bisoprolol + hctz, uncompensated heart insufficiency, pulmonary hypertension, cardiogenic shock, av block, grades ii and iii. sick sinus syndrome (in the absence of cardiac pacemakers), sinoatrial heart block, severe bradycardia with less than 50 beats/min from the start of treatment, hypotension(systolic less than 90 mmhg), acute asthmatic attack, intravenous administration of calcium antagonists of verapamil type, simultaneous treatment with monoamine oxidase inhibitors (mao-inhibitors), advanced stages of peripheral circulation disorder, severe therapy-resistant potassium deficiency, severe hyponatraemia, hypercalcaemia, severe renal dysfunction (serum creatinin over 1.8 mg/100 ml and/or creatinin clearance under 30 ml/min); acute glomerulonephritis; liver coma; children, not previously treated; pregnancy and breastfeeding
Description

Medical condition Contraindicated Bisoprolol / Hydrochlorothiazide | Hypersensitivity Bisoprolol / Hydrochlorothiazide | Heart failure Uncompensated | Pulmonary Hypertension | Shock, Cardiogenic | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Artificial cardiac pacemaker Absent | Sinoatrial Block | Bradycardia, severe | Hypotension | Systolic Pressure | Asthma attack | Verapamil Intravenous | Monoamine Oxidase Inhibitors | Poor peripheral circulation Advanced phase | Potassium Deficiency Treatment Resistant Severe | Hyponatremia Severe | Hypercalcemia | Renal dysfunction Severe | Creatinine measurement, serum | Creatinine clearance measurement | Glomerulonephritis | Hepatic Coma | Children Untreated | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0717511
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0717511
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0205433
UMLS CUI [4]
C0020542
UMLS CUI [5]
C0036980
UMLS CUI [6]
C0264906
UMLS CUI [7]
C0151517
UMLS CUI [8]
C0037052
UMLS CUI [9,1]
C0030163
UMLS CUI [9,2]
C0332197
UMLS CUI [10]
C0037188
UMLS CUI [11]
C4313412
UMLS CUI [12]
C0020649
UMLS CUI [13]
C0871470
UMLS CUI [14]
C0347950
UMLS CUI [15,1]
C0042523
UMLS CUI [15,2]
C1522726
UMLS CUI [16]
C0026457
UMLS CUI [17,1]
C0520547
UMLS CUI [17,2]
C0205179
UMLS CUI [18,1]
C0032827
UMLS CUI [18,2]
C0871547
UMLS CUI [18,3]
C0205082
UMLS CUI [19,1]
C0020625
UMLS CUI [19,2]
C0205082
UMLS CUI [20]
C0020437
UMLS CUI [21,1]
C3279454
UMLS CUI [21,2]
C0205082
UMLS CUI [22]
C0201976
UMLS CUI [23]
C0373595
UMLS CUI [24]
C0017658
UMLS CUI [25]
C0019147
UMLS CUI [26,1]
C0008059
UMLS CUI [26,2]
C0332155
UMLS CUI [27]
C0032961
UMLS CUI [28]
C0006147

Similar models

Eligibility Hypertension NCT01109043

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Tachycardia
Item
subjects with high blood pressure (bp) and tachycardia
boolean
C0020538 (UMLS CUI [1])
C0039231 (UMLS CUI [2])
Hypotension Essential | Angina Pectoris
Item
subjects with essential hypotonia, angina pectoris
boolean
C0020649 (UMLS CUI [1,1])
C0205224 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
Essential Hypertension | Adrenergic beta-1 Receptor Antagonists ineffective | Diuretics ineffective
Item
subjects with essential hypertonia, when a therapy with ß-blockers or diuretics is not sufficiently effective
boolean
C0085580 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3,1])
C3242229 (UMLS CUI [3,2])
Precautions | Poor peripheral circulation | Diabetes Mellitus | Metabolic acidosis | First degree atrioventricular block | Angina Pectoris, Variant | Angiotensin-Converting Enzyme Inhibitors | Coronary Arteriosclerosis Severe | Tuberous Sclerosis Severe | Hyperuricemia | Gout | Allergic Reaction Severe | Hypersensitivity desensitization | Anaphylaxis Excessive | Other Coding
Item
precautions to be taken in case of severe peripheral circulation disorders, diabetes (especially at the time, when blood sugar is elevated), during a strict fast, in case of metabolic acidosis, atrioventricular block (av) block of grade i, prinzmetal angina, additional therapy with angiotensin-converting enzyme inhibitors (ace-inhibitors), severe coronary or cerebral sclerosis, hyperuricemia or gout and in subjects with a history of severe hypersensitive reactions or during a desensitization therapy (excessive anaphylactic reaction, attenuated adrenergic counterregulation)
boolean
C1882442 (UMLS CUI [1])
C0520547 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0220981 (UMLS CUI [4])
C0085614 (UMLS CUI [5])
C0002963 (UMLS CUI [6])
C0003015 (UMLS CUI [7])
C0010054 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0041341 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0740394 (UMLS CUI [10])
C0018099 (UMLS CUI [11])
C1527304 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0178702 (UMLS CUI [13])
C0002792 (UMLS CUI [14,1])
C0442802 (UMLS CUI [14,2])
C3846158 (UMLS CUI [15])
Precautions Special | Family history Psoriasis | Psoriasis | Lung Diseases, Obstructive | Bronchoconstriction | Adrenergic beta-1 Receptor Antagonists | Concor | Pheochromocytoma
Item
special precautions must be taken with the subjects that have a family history or suffered from psoriasis, during a desensitization therapy (also anamnestic subjects), other obstructive pulmonary diseases on account of the possibility of initiation or intensification of bronchoconstriction, although, due to the marked ß1-selectivity of bisoprolol, the risk is lower than with non-selective ß-receptor blockers. the subjects that have a family history or suffered from psoriasis should the take concor plus only after a careful assessment of risk - benefit ratio. the subjects with pheochromocytoma should take concor plus, as well as other ß-blockers after inhibiting the alpha-receptors
boolean
C1882442 (UMLS CUI [1,1])
C0205555 (UMLS CUI [1,2])
C0455439 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
C0600260 (UMLS CUI [4])
C0079043 (UMLS CUI [5])
C0304516 (UMLS CUI [6])
C0110591 (UMLS CUI [7])
C0031511 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Heart failure | Sick Sinus Syndrome | Bradycardia | Anemia
Item
subjects with acute cardiac insufficiency, sinus sick syndrome, bradycardia and anaemia
boolean
C0018801 (UMLS CUI [1])
C0037052 (UMLS CUI [2])
C0428977 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
Medical condition Contraindicated Bisoprolol | Hypersensitivity Bisoprolol | Hypersensitivity Inactive ingredient Medication | Heart failure | Decompensated cardiac failure | Requirement Inotropic agent | Shock, Cardiogenic | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent | Sick Sinus Syndrome | Sinoatrial Block | BRADYCARDIA SYMPTOMATIC | Hypotension symptomatic | Severe asthma | Severe chronic obstructive pulmonary disease | Peripheral Arterial Disease Advanced | Raynaud Disease | Pheochromocytoma Untreated | Metabolic acidosis
Item
contraindicated medical conditions for bisoprolol as defined in the product information, i.e. a known hypersensitivity to the active agent bisoprolol or one of the inactive ingredients of the medication; acute heart failure or decompensation of heart insufficiency, that requires a therapy with inotropic agents; cardiogenic shock; av block grade ii or iii (in the absence of cardiac pacemakers); sick sinus syndrome, sinoatrial heart block; symptomatic bradycardia; symptomatic hypotonia; severe asthma bronchiolus or severe chronic obstructive airways disease; advanced stages of peripheral arterial disease or raynaud's syndrome; untreated pheochromocytoma, metabolic acidosis
boolean
C3843040 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0053799 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0053799 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1552019 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4])
C0581377 (UMLS CUI [5])
C1514873 (UMLS CUI [6,1])
C0304509 (UMLS CUI [6,2])
C0036980 (UMLS CUI [7])
C0264906 (UMLS CUI [8])
C0151517 (UMLS CUI [9])
C0030163 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0037052 (UMLS CUI [11])
C0037188 (UMLS CUI [12])
C0741627 (UMLS CUI [13])
C0863113 (UMLS CUI [14])
C0581126 (UMLS CUI [15])
C0730607 (UMLS CUI [16])
C1704436 (UMLS CUI [17,1])
C0205179 (UMLS CUI [17,2])
C0034734 (UMLS CUI [18])
C0031511 (UMLS CUI [19,1])
C0332155 (UMLS CUI [19,2])
C0220981 (UMLS CUI [20])
Medical condition Contraindicated Bisoprolol / Hydrochlorothiazide | Hypersensitivity Bisoprolol / Hydrochlorothiazide | Heart failure Uncompensated | Pulmonary Hypertension | Shock, Cardiogenic | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Artificial cardiac pacemaker Absent | Sinoatrial Block | Bradycardia, severe | Hypotension | Systolic Pressure | Asthma attack | Verapamil Intravenous | Monoamine Oxidase Inhibitors | Poor peripheral circulation Advanced phase | Potassium Deficiency Treatment Resistant Severe | Hyponatremia Severe | Hypercalcemia | Renal dysfunction Severe | Creatinine measurement, serum | Creatinine clearance measurement | Glomerulonephritis | Hepatic Coma | Children Untreated | Pregnancy | Breast Feeding
Item
contraindicated medical conditions for bisoprolol + hydrochlorothiazide (hctz) as defined in the product information, i.e. hypersensitivity to the ingredients of the medication containing bisoprolol + hctz, uncompensated heart insufficiency, pulmonary hypertension, cardiogenic shock, av block, grades ii and iii. sick sinus syndrome (in the absence of cardiac pacemakers), sinoatrial heart block, severe bradycardia with less than 50 beats/min from the start of treatment, hypotension(systolic less than 90 mmhg), acute asthmatic attack, intravenous administration of calcium antagonists of verapamil type, simultaneous treatment with monoamine oxidase inhibitors (mao-inhibitors), advanced stages of peripheral circulation disorder, severe therapy-resistant potassium deficiency, severe hyponatraemia, hypercalcaemia, severe renal dysfunction (serum creatinin over 1.8 mg/100 ml and/or creatinin clearance under 30 ml/min); acute glomerulonephritis; liver coma; children, not previously treated; pregnancy and breastfeeding
boolean
C3843040 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0717511 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0717511 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0020542 (UMLS CUI [4])
C0036980 (UMLS CUI [5])
C0264906 (UMLS CUI [6])
C0151517 (UMLS CUI [7])
C0037052 (UMLS CUI [8])
C0030163 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0037188 (UMLS CUI [10])
C4313412 (UMLS CUI [11])
C0020649 (UMLS CUI [12])
C0871470 (UMLS CUI [13])
C0347950 (UMLS CUI [14])
C0042523 (UMLS CUI [15,1])
C1522726 (UMLS CUI [15,2])
C0026457 (UMLS CUI [16])
C0520547 (UMLS CUI [17,1])
C0205179 (UMLS CUI [17,2])
C0032827 (UMLS CUI [18,1])
C0871547 (UMLS CUI [18,2])
C0205082 (UMLS CUI [18,3])
C0020625 (UMLS CUI [19,1])
C0205082 (UMLS CUI [19,2])
C0020437 (UMLS CUI [20])
C3279454 (UMLS CUI [21,1])
C0205082 (UMLS CUI [21,2])
C0201976 (UMLS CUI [22])
C0373595 (UMLS CUI [23])
C0017658 (UMLS CUI [24])
C0019147 (UMLS CUI [25])
C0008059 (UMLS CUI [26,1])
C0332155 (UMLS CUI [26,2])
C0032961 (UMLS CUI [27])
C0006147 (UMLS CUI [28])

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