ID

29838

Beschrijving

The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01049009

Link

https://clinicaltrials.gov/show/NCT01049009

Trefwoorden

Versies (1)
  1. 23-04-18 23-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility High Blood Pressure NCT01049009

Engels

Eligibility High Blood Pressure NCT01049009

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or post-menopausal females aged 18-80 years.
Beschrijving

Age | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
subjects self-identified as black or african-american.
Beschrijving

Black | African American

Datatype

boolean

Alias
UMLS CUI [1]
C0005680
UMLS CUI [2]
C0085756
diagnosis of hypertension.
Beschrijving

Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
patients on current anti-hypertensive therapy that does not include beta blockade should have bp >135/85.
Beschrijving

Antihypertensive therapy | Adrenergic beta-1 Receptor Antagonists Excluded | Blood pressure determination

Datatype

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C0332196
UMLS CUI [3]
C0005824
patients on anti-hypertensive therapy including beta blockers will have their beta blockers discontinued gradually over 2 weeks before enrolment.
Beschrijving

Antihypertensive therapy | Adrenergic beta-1 Receptor Antagonists Discontinued Gradual

Datatype

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0439833
concomitant therapy: patients will be allowed to be on concomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of hypertension), clonidine, or vasodilators. patients will be on stable medical therapy for at least 2 months before recruitment. patients with previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol, and labetalol) will also be eligible to participate, but will be randomized to the study beta blocker.
Beschrijving

Aspirin | Statins | Thiazide Diuretics | Calcium Channel Blockers Hypertensive disease | Clonidine | Vasodilator Agents | Therapeutic procedure Stable | Adrenergic beta-1 Receptor Antagonists | Metoprolol | Propranolol | Atenolol | Labetalol

Datatype

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0360714
UMLS CUI [3]
C0012802
UMLS CUI [4,1]
C0006684
UMLS CUI [4,2]
C0020538
UMLS CUI [5]
C0009014
UMLS CUI [6]
C0042402
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0205360
UMLS CUI [8]
C0304516
UMLS CUI [9]
C0025859
UMLS CUI [10]
C0033497
UMLS CUI [11]
C0004147
UMLS CUI [12]
C0022860
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
initiation or change in dose of statin or other anti-hypertensive therapy within 2 months before the study
Beschrijving

Initiation Statin | Statin Dose Change | Initiation Antihypertensive therapy | Antihypertensive therapy Dose Change

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0360714
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C1704686
UMLS CUI [3,2]
C0585941
UMLS CUI [4,1]
C0585941
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0392747
inability to return to emory for follow-up testing
Beschrijving

Follow-up Testing Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1272705
age < 21 or >80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
premenopausal females with potential for pregnancy
Beschrijving

Premenopausal state | Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C3831118
acute infection in previous 2 weeks
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
on angiotensin antagonists (ace inhibitors or arbs)
Beschrijving

Angiotensin Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C0815017
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
history of substance abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
current neoplasm
Beschrijving

Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0027651
chronic renal failure [creatinine > 2.5 mg/dl] or liver failure (liver enzymes >2x normal)
Beschrijving

Kidney Failure, Chronic | Creatinine measurement, serum | Chronic Liver Failure | Elevated liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2936476
UMLS CUI [4]
C0235996
acute coronary syndrome, class iv heart failure, cva, coronary intervention within 2 months
Beschrijving

Acute Coronary Syndrome | Heart failure New York Heart Association Classification | Cerebrovascular accident | Intervention Coronary

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C1522318
known aortic stenosis, hypertrophic cardiomyopathy.
Beschrijving

Aortic Stenosis | Hypertrophic Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C0007194
inability to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility High Blood Pressure NCT01049009

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal state
Item
male or post-menopausal females aged 18-80 years.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Black | African American
Item
subjects self-identified as black or african-american.
boolean
C0005680 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Hypertensive disease
Item
diagnosis of hypertension.
boolean
C0020538 (UMLS CUI [1])
Antihypertensive therapy | Adrenergic beta-1 Receptor Antagonists Excluded | Blood pressure determination
Item
patients on current anti-hypertensive therapy that does not include beta blockade should have bp >135/85.
boolean
C0585941 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0005824 (UMLS CUI [3])
Antihypertensive therapy | Adrenergic beta-1 Receptor Antagonists Discontinued Gradual
Item
patients on anti-hypertensive therapy including beta blockers will have their beta blockers discontinued gradually over 2 weeks before enrolment.
boolean
C0585941 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0439833 (UMLS CUI [2,3])
Aspirin | Statins | Thiazide Diuretics | Calcium Channel Blockers Hypertensive disease | Clonidine | Vasodilator Agents | Therapeutic procedure Stable | Adrenergic beta-1 Receptor Antagonists | Metoprolol | Propranolol | Atenolol | Labetalol
Item
concomitant therapy: patients will be allowed to be on concomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of hypertension), clonidine, or vasodilators. patients will be on stable medical therapy for at least 2 months before recruitment. patients with previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol, and labetalol) will also be eligible to participate, but will be randomized to the study beta blocker.
boolean
C0004057 (UMLS CUI [1])
C0360714 (UMLS CUI [2])
C0012802 (UMLS CUI [3])
C0006684 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C0009014 (UMLS CUI [5])
C0042402 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0205360 (UMLS CUI [7,2])
C0304516 (UMLS CUI [8])
C0025859 (UMLS CUI [9])
C0033497 (UMLS CUI [10])
C0004147 (UMLS CUI [11])
C0022860 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Initiation Statin | Statin Dose Change | Initiation Antihypertensive therapy | Antihypertensive therapy Dose Change
Item
initiation or change in dose of statin or other anti-hypertensive therapy within 2 months before the study
boolean
C1704686 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0360714 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C1704686 (UMLS CUI [3,1])
C0585941 (UMLS CUI [3,2])
C0585941 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
Follow-up Testing Unsuccessful
Item
inability to return to emory for follow-up testing
boolean
C3274571 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Age
Item
age < 21 or >80 years
boolean
C0001779 (UMLS CUI [1])
Premenopausal state | Childbearing Potential
Item
premenopausal females with potential for pregnancy
boolean
C0232969 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Communicable Disease
Item
acute infection in previous 2 weeks
boolean
C0009450 (UMLS CUI [1])
Angiotensin Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
on angiotensin antagonists (ace inhibitors or arbs)
boolean
C0815017 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Use Disorders
Item
history of substance abuse
boolean
C0038586 (UMLS CUI [1])
Neoplasm
Item
current neoplasm
boolean
C0027651 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine measurement, serum | Chronic Liver Failure | Elevated liver enzymes
Item
chronic renal failure [creatinine > 2.5 mg/dl] or liver failure (liver enzymes >2x normal)
boolean
C0022661 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2936476 (UMLS CUI [3])
C0235996 (UMLS CUI [4])
Acute Coronary Syndrome | Heart failure New York Heart Association Classification | Cerebrovascular accident | Intervention Coronary
Item
acute coronary syndrome, class iv heart failure, cva, coronary intervention within 2 months
boolean
C0948089 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C1522318 (UMLS CUI [4,2])
Aortic Stenosis | Hypertrophic Cardiomyopathy
Item
known aortic stenosis, hypertrophic cardiomyopathy.
boolean
C0003507 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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