ID

12873

Descrição

EnligHTN German Observational Study; ODM derived from: https://clinicaltrials.gov/show/NCT01996033

Link

https://clinicaltrials.gov/show/NCT01996033

Palavras-chave

  1. 04/01/2016 04/01/2016 -
Transferido a

4 de janeiro de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Uncontrolled Hypertension NCT01996033

Eligibility Uncontrolled Hypertension NCT01996033

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is planned to undergo a renal denervation procedure for the treatment of hypertension
Descrição

denervation renal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011307
UMLS CUI [1,2]
C0022646
subject is ≥18 years of age at time of consent
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject must be able and willing to provide written informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subject must be able and willing to comply with the required follow-up schedule
Descrição

compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
subject has office systolic blood pressure (sbp) ≥ 140 mmhg
Descrição

systolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ace-i/ angiotensin receptor blocker (arb), calcium channel blockers, beta blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
Descrição

hypertension; anti-hypertensive medications

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0003364
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
Descrição

renal artery stenosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035067
subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
Descrição

renal angioplasty; renal stents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1282893
UMLS CUI [2]
C1262325
subject has a history of hemodynamically significant valvular heart disease
Descrição

valvular heart disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
subject has blood clotting abnormalities
Descrição

coagulopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
subject life expectancy is < 12 months, as determined by the study investigator
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
subject is participating in another clinical study which has the potential
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Uncontrolled Hypertension NCT01996033

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
denervation renal
Item
subject is planned to undergo a renal denervation procedure for the treatment of hypertension
boolean
C0011307 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
age
Item
subject is ≥18 years of age at time of consent
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
subject must be able and willing to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
compliance behavior
Item
subject must be able and willing to comply with the required follow-up schedule
boolean
C1321605 (UMLS CUI [1])
systolic blood pressure
Item
subject has office systolic blood pressure (sbp) ≥ 140 mmhg
boolean
C0871470 (UMLS CUI [1])
hypertension; anti-hypertensive medications
Item
subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ace-i/ angiotensin receptor blocker (arb), calcium channel blockers, beta blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
boolean
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
renal artery stenosis
Item
subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
boolean
C0035067 (UMLS CUI [1])
renal angioplasty; renal stents
Item
subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
boolean
C1282893 (UMLS CUI [1])
C1262325 (UMLS CUI [2])
valvular heart disease
Item
subject has a history of hemodynamically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1])
coagulopathy
Item
subject has blood clotting abnormalities
boolean
C0005779 (UMLS CUI [1])
life expectancy
Item
subject life expectancy is < 12 months, as determined by the study investigator
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status
Item
subject is participating in another clinical study which has the potential
boolean
C2348568 (UMLS CUI [1])

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