ID

30150

Beschreibung

Angiotensin-converting-enzyme (ACE) Inhibitors in Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00985322

Link

https://clinicaltrials.gov/show/NCT00985322

Stichworte

Versionen (1)
  1. 15.05.18 15.05.18 -
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See clinicaltrials.gov

Hochgeladen am

15. Mai 2018

DOI

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Creative Commons BY 4.0
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Eligibility Left Ventricular Hypertrophy NCT00985322

Englisch

Eligibility Left Ventricular Hypertrophy NCT00985322

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women >18 years of age who are on chronic renal replacement treatment since at least 6 months with two or three haemodialysis sessions per week.
Beschreibung

Age | Renal Replacement Therapy chronic | Hemodialysis Quantity per week

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0206074
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0019004
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332174
hypertension (pre-dialysis systolic and/or diastolic bp >140/90 mmhg or post-dialysis systolic and/or diastolic bp >130/80 mmhg or ongoing antihypertensive therapy).
Beschreibung

Hypertensive disease | Systolic Pressure Pre-dialysis | Diastolic blood pressure Pre-dialysis | Systolic Pressure Post-dialysis | Diastolic blood pressure Post-dialysis | Antihypertensive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C1264634
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C1264634
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C1264635
UMLS CUI [5,1]
C0428883
UMLS CUI [5,2]
C1264635
UMLS CUI [6]
C0585941
and/or
Beschreibung

ID.3

Datentyp

boolean

lvh defined by a cardiac mass index >130 g/m2 for men and 100 g/m2 for women (17) within three months of enrolment.
Beschreibung

Left Ventricular Hypertrophy | Cardiac Mass Index | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0149721
UMLS CUI [2,1]
C3670832
UMLS CUI [2,2]
C0918012
UMLS CUI [3]
C0079399
written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
specific indication (such as heart failure) or contraindication (such as hypersensitivity) to ace inhibitor therapy.
Beschreibung

Indication Angiotensin converting enzyme inhibitor therapy | Heart failure | Medical contraindication Angiotensin converting enzyme inhibitor therapy | Angiotensin-converting-enzyme inhibitor allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1444755
UMLS CUI [2]
C0018801
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1444755
UMLS CUI [4]
C0571939
any concomitant medication with ace inhibitors and angiotensin ii receptor antagonists
Beschreibung

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
hyperkalemia (serum potassium >6 meq/l) despite optimal control of metabolic acidosis and blood glucose (in diabetics) in patient with less then three dialysis sessions per week.
Beschreibung

Hyperkalemia | Serum potassium measurement | Control Optimum Metabolic acidosis Diabetics | Control Optimum Blood Glucose Diabetics | Dialysis procedure Quantity per week

Datentyp

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0302353
UMLS CUI [3,1]
C2587213
UMLS CUI [3,2]
C2698651
UMLS CUI [3,3]
C0220981
UMLS CUI [3,4]
C0241863
UMLS CUI [4,1]
C2587213
UMLS CUI [4,2]
C2698651
UMLS CUI [4,3]
C0005802
UMLS CUI [4,4]
C0241863
UMLS CUI [5,1]
C0011946
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0332174
symptomatic chronic or intradialytic hypotension.
Beschreibung

Chronic hypotension Symptomatic | Hypotension intradialytic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155800
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1260413
arrhythmias that in the investigator judgement might be worsened by hyperkalemia (such as sinus bradycardia, delayed atrio-ventricular conduction, atrio-ventricular blocks).
Beschreibung

Cardiac Arrhythmia Worsened Due to Hyperkalemia | Sinus bradycardia | Atrioventricular conduction Delayed | Atrioventricular Block

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1457868
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0020461
UMLS CUI [2]
C0085610
UMLS CUI [3,1]
C4025244
UMLS CUI [3,2]
C0205421
UMLS CUI [4]
C0004245
cv events (stroke, acute myocardial infarction or other acute coronary syndromes) over the last three months.
Beschreibung

Cardiovascular event | Cerebrovascular accident | Myocardial Infarction | Acute Coronary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0948089
uncontrolled hyper- or hypo-thyroidism.
Beschreibung

Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C0205318
active systemic disease, malignancies and any clinical condition associated with a life-expectancy of less than 2 years.
Beschreibung

Systemic disease | Malignant Neoplasms | Medical condition Associated with Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0023671
drug or alcohol abuse, psychiatric disorders and inability to understand the potential risks or benefits of the study.
Beschreibung

Substance Use Disorders | Mental disorders | Comprehension Study Protocol Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
UMLS CUI [3,3]
C1299582
pregnancy, lactation or child bearing potential and ineffective contraception.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods ineffective

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C3242229
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Ähnliche Modelle

Eligibility Left Ventricular Hypertrophy NCT00985322

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Renal Replacement Therapy chronic | Hemodialysis Quantity per week
Item
men and women >18 years of age who are on chronic renal replacement treatment since at least 6 months with two or three haemodialysis sessions per week.
boolean
C0001779 (UMLS CUI [1])
C0206074 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0019004 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332174 (UMLS CUI [3,3])
Hypertensive disease | Systolic Pressure Pre-dialysis | Diastolic blood pressure Pre-dialysis | Systolic Pressure Post-dialysis | Diastolic blood pressure Post-dialysis | Antihypertensive therapy
Item
hypertension (pre-dialysis systolic and/or diastolic bp >140/90 mmhg or post-dialysis systolic and/or diastolic bp >130/80 mmhg or ongoing antihypertensive therapy).
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C1264634 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C1264634 (UMLS CUI [3,2])
C0871470 (UMLS CUI [4,1])
C1264635 (UMLS CUI [4,2])
C0428883 (UMLS CUI [5,1])
C1264635 (UMLS CUI [5,2])
C0585941 (UMLS CUI [6])
ID.3
Item
and/or
boolean
Left Ventricular Hypertrophy | Cardiac Mass Index | Gender
Item
lvh defined by a cardiac mass index >130 g/m2 for men and 100 g/m2 for women (17) within three months of enrolment.
boolean
C0149721 (UMLS CUI [1])
C3670832 (UMLS CUI [2,1])
C0918012 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Indication Angiotensin converting enzyme inhibitor therapy | Heart failure | Medical contraindication Angiotensin converting enzyme inhibitor therapy | Angiotensin-converting-enzyme inhibitor allergy
Item
specific indication (such as heart failure) or contraindication (such as hypersensitivity) to ace inhibitor therapy.
boolean
C3146298 (UMLS CUI [1,1])
C1444755 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C1444755 (UMLS CUI [3,2])
C0571939 (UMLS CUI [4])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
any concomitant medication with ace inhibitors and angiotensin ii receptor antagonists
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
Hyperkalemia | Serum potassium measurement | Control Optimum Metabolic acidosis Diabetics | Control Optimum Blood Glucose Diabetics | Dialysis procedure Quantity per week
Item
hyperkalemia (serum potassium >6 meq/l) despite optimal control of metabolic acidosis and blood glucose (in diabetics) in patient with less then three dialysis sessions per week.
boolean
C0020461 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
C2587213 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
C0220981 (UMLS CUI [3,3])
C0241863 (UMLS CUI [3,4])
C2587213 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
C0005802 (UMLS CUI [4,3])
C0241863 (UMLS CUI [4,4])
C0011946 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0332174 (UMLS CUI [5,3])
Chronic hypotension Symptomatic | Hypotension intradialytic
Item
symptomatic chronic or intradialytic hypotension.
boolean
C0155800 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1260413 (UMLS CUI [2])
Cardiac Arrhythmia Worsened Due to Hyperkalemia | Sinus bradycardia | Atrioventricular conduction Delayed | Atrioventricular Block
Item
arrhythmias that in the investigator judgement might be worsened by hyperkalemia (such as sinus bradycardia, delayed atrio-ventricular conduction, atrio-ventricular blocks).
boolean
C0003811 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0020461 (UMLS CUI [1,4])
C0085610 (UMLS CUI [2])
C4025244 (UMLS CUI [3,1])
C0205421 (UMLS CUI [3,2])
C0004245 (UMLS CUI [4])
Cardiovascular event | Cerebrovascular accident | Myocardial Infarction | Acute Coronary Syndrome
Item
cv events (stroke, acute myocardial infarction or other acute coronary syndromes) over the last three months.
boolean
C1320716 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled
Item
uncontrolled hyper- or hypo-thyroidism.
boolean
C0020550 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Systemic disease | Malignant Neoplasms | Medical condition Associated with Life Expectancy
Item
active systemic disease, malignancies and any clinical condition associated with a life-expectancy of less than 2 years.
boolean
C0442893 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
Substance Use Disorders | Mental disorders | Comprehension Study Protocol Unable
Item
drug or alcohol abuse, psychiatric disorders and inability to understand the potential risks or benefits of the study.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods ineffective
Item
pregnancy, lactation or child bearing potential and ineffective contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3242229 (UMLS CUI [3,3])
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