ID

40315

Beschrijving

Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart; ODM derived from: https://clinicaltrials.gov/show/NCT01961323

Link

https://clinicaltrials.gov/show/NCT01961323

Trefwoorden

Versies (1)
  1. 06-04-20 06-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01961323

Engels

Eligibility Hypertension NCT01961323

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of mild (140-160 / 90-100) to moderate (160-200 / 100-120) hypertension
Beschrijving

Hypertension, mild | Blood pressure determination | Hypertension, moderate

Datatype

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2]
C0005824
UMLS CUI [3]
C1969581
no medical treatment for elevated bp
Beschrijving

Therapeutic procedure Absent | Increase in blood pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0497247
lv diastolic dysfunction (>/= grade1)
Beschrijving

Left ventricular diastolic dysfunction Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C1273070
UMLS CUI [1,2]
C0441800
lv ejection fraction >50%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
indexed left atrial volume >/= 28 ml/m^2
Beschrijving

Left atrial Volume

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0449468
in sinus rhythm at the time of enrollment
Beschrijving

Sinus rhythm

Datatype

boolean

Alias
UMLS CUI [1]
C0232201
willingness to return for the 6-month follow up investigations
Beschrijving

Follow-up Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of any of the following at baseline:
Beschrijving

Exclusion Criteria Any Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. history of mitral valve disease of greater than mild severity or prosthetic mitral valve, congenital heart disease or permanent pacemaker
Beschrijving

Diseases of mitral valve Moderate | Diseases of mitral valve Severe | Mitral valve prosthesis | Congenital heart disease | Permanent pacemaker

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026265
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0182494
UMLS CUI [4]
C0152021
UMLS CUI [5]
C0281945
2. calculated creatinine clearance <50 ml/min
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
3. terminal illness with expected survival of <1 year
Beschrijving

Terminal illness | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0023671
4. previous heart transplant
Beschrijving

Heart Transplantation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0205156
5. individuals who are institutionalized
Beschrijving

Institutionalized Persons

Datatype

boolean

Alias
UMLS CUI [1]
C0376326
6. systolic bp>180 mm hg or diastolic bp > 120 mm hg
Beschrijving

Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
patient unwilling or unable to provide informed consent for study participation
Beschrijving

Informed Consent Unwilling | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
pregnancy (current, or anticipated within the study period)
Beschrijving

Pregnancy | Pregnancy Anticipated

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C3840775
secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
previous echo contrast allergy
Beschrijving

Hypersensitivity Echocardiography Contrast Media

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013516
UMLS CUI [1,3]
C0009924
poor echocardiography window
Beschrijving

Echocardiography Poor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C2700379
previous stroke, known carotid stenosis
Beschrijving

Cerebrovascular accident Previous | Carotid Stenosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007282
contraindication for beta-blocker therapy (sinus bradycardia <50 beats/min);
Beschrijving

Medical contraindication Adrenergic beta-1 Receptor Antagonists | Sinus bradycardia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0304516
UMLS CUI [2]
C0085610
2nd or 3rd degree av conduction block
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
overt congestive cardiac failure (nyha class iii-iv)
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
known bronchospastic disease
Beschrijving

Bronchial Spasm

Datatype

boolean

Alias
UMLS CUI [1]
C0006266
known hepatic dysfunction (sgot/pt > twice above normal levels)
Beschrijving

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
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Similar models

Eligibility Hypertension NCT01961323

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hypertension, mild | Blood pressure determination | Hypertension, moderate
Item
history of mild (140-160 / 90-100) to moderate (160-200 / 100-120) hypertension
boolean
C3276943 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C1969581 (UMLS CUI [3])
Therapeutic procedure Absent | Increase in blood pressure
Item
no medical treatment for elevated bp
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0497247 (UMLS CUI [2])
Left ventricular diastolic dysfunction Grade
Item
lv diastolic dysfunction (>/= grade1)
boolean
C1273070 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lv ejection fraction >50%
boolean
C0428772 (UMLS CUI [1])
Left atrial Volume
Item
indexed left atrial volume >/= 28 ml/m^2
boolean
C0225860 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Sinus rhythm
Item
in sinus rhythm at the time of enrollment
boolean
C0232201 (UMLS CUI [1])
Follow-up Compliance
Item
willingness to return for the 6-month follow up investigations
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any Fulfill
Item
presence or history of any of the following at baseline:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Diseases of mitral valve Moderate | Diseases of mitral valve Severe | Mitral valve prosthesis | Congenital heart disease | Permanent pacemaker
Item
1. history of mitral valve disease of greater than mild severity or prosthetic mitral valve, congenital heart disease or permanent pacemaker
boolean
C0026265 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0182494 (UMLS CUI [3])
C0152021 (UMLS CUI [4])
C0281945 (UMLS CUI [5])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
2. calculated creatinine clearance <50 ml/min
boolean
C2711451 (UMLS CUI [1])
Terminal illness | Life Expectancy
Item
3. terminal illness with expected survival of <1 year
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Heart Transplantation Previous
Item
4. previous heart transplant
boolean
C0018823 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Institutionalized Persons
Item
5. individuals who are institutionalized
boolean
C0376326 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
6. systolic bp>180 mm hg or diastolic bp > 120 mm hg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Informed Consent Unwilling | Informed Consent Unable
Item
patient unwilling or unable to provide informed consent for study participation
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Pregnancy | Pregnancy Anticipated
Item
pregnancy (current, or anticipated within the study period)
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Hypersensitivity Echocardiography Contrast Media
Item
previous echo contrast allergy
boolean
C0020517 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
Echocardiography Poor
Item
poor echocardiography window
boolean
C0013516 (UMLS CUI [1,1])
C2700379 (UMLS CUI [1,2])
Cerebrovascular accident Previous | Carotid Stenosis
Item
previous stroke, known carotid stenosis
boolean
C0038454 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007282 (UMLS CUI [2])
Medical contraindication Adrenergic beta-1 Receptor Antagonists | Sinus bradycardia
Item
contraindication for beta-blocker therapy (sinus bradycardia <50 beats/min);
boolean
C1301624 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0085610 (UMLS CUI [2])
Second degree atrioventricular block | Complete atrioventricular block
Item
2nd or 3rd degree av conduction block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
overt congestive cardiac failure (nyha class iii-iv)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Bronchial Spasm
Item
known bronchospastic disease
boolean
C0006266 (UMLS CUI [1])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
known hepatic dysfunction (sgot/pt > twice above normal levels)
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
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