ID

40347

Beschreibung

Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial); ODM derived from: https://clinicaltrials.gov/show/NCT02268071

Link

https://clinicaltrials.gov/show/NCT02268071

Stichworte

Versionen (1)
  1. 10.04.20 10.04.20 -
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See clinicaltrials.gov

Hochgeladen am

10. April 2020

DOI

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Eligibility Hypertension NCT02268071

Englisch

Eligibility Hypertension NCT02268071

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ambulatory patient above 18 years old, consulting a general practitioner.
Beschreibung

Outpatient Consulting General Practitioner | Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0009818
UMLS CUI [1,3]
C0017319
UMLS CUI [2]
C0001779
grade i hypertension at diagnosis.
Beschreibung

Hypertensive disease Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0441800
hypertension diagnosed and treated by antihypertensive drug for at least two years.
Beschreibung

Hypertensive disease | Antihypertensive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0003364
controlled hypertension (clinical bp < 140/90 mmhg) or uncontrolled hypertension (clinical bp > or equal to 140/90 mmhg) without modification of treatment for at least 6 months, by a monotherapy or a low dose dual therapy.
Beschreibung

Hypertension controlled | Blood pressure determination | Uncontrolled hypertension | Therapy unchanged | Low-Dose Treatment Dual

Datentyp

boolean

Alias
UMLS CUI [1]
C0745117
UMLS CUI [2]
C0005824
UMLS CUI [3]
C1868885
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0442739
UMLS CUI [5,1]
C1708745
UMLS CUI [5,2]
C0205173
hbpm values < 135/85mmhg (in order to exclude masked hypertension).
Beschreibung

Blood pressure determination Home Blood Pressure Monitoring | Masked Hypertension Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C1449681
UMLS CUI [2,1]
C3178811
UMLS CUI [2,2]
C0332196
patient having signed the informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patient affiliated to a national insurance scheme.
Beschreibung

Patients Affiliated National Health Insurance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C0027452
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
personal cardiovascular history and/or necessity to take the antihypertensive treatment for another reason than hypertension (heart failure, migraine, peripheral arterial disease, coronary heart disease, stroke…).
Beschreibung

Cardiovascular History | Patient need for Antihypertensive therapy | Etiology Heart failure | Etiology Migraine Disorders | Etiology Peripheral Arterial Diseases | Etiology Coronary heart disease | Etiology Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C1880008
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0585941
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0018801
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0149931
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C1704436
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0010068
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C0038454
target organ damage (evidence of ventricular hypertrophy by ecg or cardiac echography and/or proteinuria and/or pathological micro-albuminuria presence showing a nephropathy, in the last year).
Beschreibung

Target Organ Damage | Ventricular hypertrophy by EKG | Ventricular hypertrophy Echocardiography | Proteinuria | Microalbuminuria | Kidney Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1883709
UMLS CUI [2]
C0232312
UMLS CUI [3,1]
C0340279
UMLS CUI [3,2]
C0013516
UMLS CUI [4]
C0033687
UMLS CUI [5]
C0730345
UMLS CUI [6]
C0022658
poorly compliant patient, whose score of girerd questionnaire is equal to or greater than 3.
Beschreibung

Poor compliance | Questionnaire Antihypertensive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032646
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0585941
existence of a progressive disease likely to impact on the life expectancy in a short term.
Beschreibung

Progressive Disease Impact Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0023671
existence of a documented atrial fibrillation (contraindication of hbpm).
Beschreibung

Atrial Fibrillation | Medical contraindication Home Blood Pressure Monitoring

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1449681
patient under a legal protection measure.
Beschreibung

Protection of patient Legal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
chronic alcohol or drug abuse, regular intake of vasopressor effect substances (licorice,cocaine,...).
Beschreibung

Substance Use Disorder chronic | Vasoconstrictor Agents Intake Regular | Licorice | Cocaine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0042397
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0205272
UMLS CUI [3]
C0086555
UMLS CUI [4]
C0009170
current known pregnancy or project of pregnancy within one year.
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Ähnliche Modelle

Eligibility Hypertension NCT02268071

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatient Consulting General Practitioner | Age
Item
ambulatory patient above 18 years old, consulting a general practitioner.
boolean
C0029921 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C0017319 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
Hypertensive disease Grade
Item
grade i hypertension at diagnosis.
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Hypertensive disease | Antihypertensive Agents
Item
hypertension diagnosed and treated by antihypertensive drug for at least two years.
boolean
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
Hypertension controlled | Blood pressure determination | Uncontrolled hypertension | Therapy unchanged | Low-Dose Treatment Dual
Item
controlled hypertension (clinical bp < 140/90 mmhg) or uncontrolled hypertension (clinical bp > or equal to 140/90 mmhg) without modification of treatment for at least 6 months, by a monotherapy or a low dose dual therapy.
boolean
C0745117 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C1708745 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
Blood pressure determination Home Blood Pressure Monitoring | Masked Hypertension Excluded
Item
hbpm values < 135/85mmhg (in order to exclude masked hypertension).
boolean
C0005824 (UMLS CUI [1,1])
C1449681 (UMLS CUI [1,2])
C3178811 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Informed Consent
Item
patient having signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Patients Affiliated National Health Insurance
Item
patient affiliated to a national insurance scheme.
boolean
C0030705 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0027452 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular History | Patient need for Antihypertensive therapy | Etiology Heart failure | Etiology Migraine Disorders | Etiology Peripheral Arterial Diseases | Etiology Coronary heart disease | Etiology Cerebrovascular accident
Item
personal cardiovascular history and/or necessity to take the antihypertensive treatment for another reason than hypertension (heart failure, migraine, peripheral arterial disease, coronary heart disease, stroke…).
boolean
C1880008 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0585941 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0149931 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C1704436 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0010068 (UMLS CUI [6,2])
C0015127 (UMLS CUI [7,1])
C0038454 (UMLS CUI [7,2])
Target Organ Damage | Ventricular hypertrophy by EKG | Ventricular hypertrophy Echocardiography | Proteinuria | Microalbuminuria | Kidney Disease
Item
target organ damage (evidence of ventricular hypertrophy by ecg or cardiac echography and/or proteinuria and/or pathological micro-albuminuria presence showing a nephropathy, in the last year).
boolean
C1521840 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1883709 (UMLS CUI [1,3])
C0232312 (UMLS CUI [2])
C0340279 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0033687 (UMLS CUI [4])
C0730345 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
Poor compliance | Questionnaire Antihypertensive therapy
Item
poorly compliant patient, whose score of girerd questionnaire is equal to or greater than 3.
boolean
C0032646 (UMLS CUI [1])
C0034394 (UMLS CUI [2,1])
C0585941 (UMLS CUI [2,2])
Progressive Disease Impact Life Expectancy
Item
existence of a progressive disease likely to impact on the life expectancy in a short term.
boolean
C1335499 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Atrial Fibrillation | Medical contraindication Home Blood Pressure Monitoring
Item
existence of a documented atrial fibrillation (contraindication of hbpm).
boolean
C0004238 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C1449681 (UMLS CUI [2,2])
Protection of patient Legal
Item
patient under a legal protection measure.
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Substance Use Disorder chronic | Vasoconstrictor Agents Intake Regular | Licorice | Cocaine
Item
chronic alcohol or drug abuse, regular intake of vasopressor effect substances (licorice,cocaine,...).
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0042397 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0086555 (UMLS CUI [3])
C0009170 (UMLS CUI [4])
Pregnancy | Pregnancy, Planned
Item
current known pregnancy or project of pregnancy within one year.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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