ID

40316

Description

Influence of Sodium Intake on Left Ventricular-arterial Coupling; ODM derived from: https://clinicaltrials.gov/show/NCT01965236

Link

https://clinicaltrials.gov/show/NCT01965236

Keywords

Versions (1)
  1. 4/7/20 4/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2020

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01965236

English

Eligibility Hypertension NCT01965236

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (<140/90 mmhg)
Description

Hypertensive disease Stage Risk Medium | Hypertensive disease Stage High risk | Therapeutic procedure Efficient | Diuretics Absent | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0439536
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0699749
UMLS CUI [2,3]
C4319571
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0442799
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0005824
high sodium intake (sodium urinary excretion for 24h (unav) > or = 170 mmol/24h before visit 0
Description

Sodium intake High | 24 hour urine sodium output measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0489645
UMLS CUI [1,2]
C0205250
UMLS CUI [2]
C1278233
limited sodium intake objective (unav<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks
Description

Sodium intake Limited | 24 hour urine sodium output measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0489645
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C1278233
patients aged between 18 and 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has given written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject has subscribed a health care insurance
Description

Health insurance coverage

Data type

boolean

Alias
UMLS CUI [1]
C2029812
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ...
Description

Complications Associated with Hypertensive disease | Cardiovascular Diseases | Myocardial Infarction | Cerebrovascular accident | Coronary heart disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020538
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0010068
arterial hypertension associated with cardiopathy
Description

Hypertensive disease Associated with Heart Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018799
arterial hypertension associated with nephropathy
Description

Hypertensive disease Associated with Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0022658
arterial hypertension associated with diabetes
Description

Hypertensive disease Associated with Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0011849
measure of central arterial pressure by tonometry is impossible
Description

Measurement of systemic arterial pressure Tonometry Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0199663
UMLS CUI [1,2]
C0040420
UMLS CUI [1,3]
C1272705
cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis
Description

Echogenicity cardiac Unsatisfactory

Data type

boolean

Alias
UMLS CUI [1,1]
C1719852
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0439856
patient refuses informed consent
Description

Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
follow-up impossible for 15 weeks
Description

Follow-up Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
pregnant or women without efficacy contraception
Description

Pregnancy | Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
patient without freedom by administration decision
Description

Patients Deprivation Freedom

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
patient in exclusion period
Description

Patients Exclusion Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C1948053
patient without french insurance
Description

Health Insurance french Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C1556084
UMLS CUI [1,3]
C0332268
adult protected by the law
Description

Protection of patient Legal

Data type

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
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Similar models

Eligibility Hypertension NCT01965236

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease Stage Risk Medium | Hypertensive disease Stage High risk | Therapeutic procedure Efficient | Diuretics Absent | Blood pressure determination
Item
hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (<140/90 mmhg)
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0439536 (UMLS CUI [1,4])
C0020538 (UMLS CUI [2,1])
C0699749 (UMLS CUI [2,2])
C4319571 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0442799 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0005824 (UMLS CUI [5])
Sodium intake High | 24 hour urine sodium output measurement
Item
high sodium intake (sodium urinary excretion for 24h (unav) > or = 170 mmol/24h before visit 0
boolean
C0489645 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1278233 (UMLS CUI [2])
Sodium intake Limited | 24 hour urine sodium output measurement
Item
limited sodium intake objective (unav<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks
boolean
C0489645 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1278233 (UMLS CUI [2])
Age
Item
patients aged between 18 and 80 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject has given written informed consent
boolean
C0021430 (UMLS CUI [1])
Health insurance coverage
Item
subject has subscribed a health care insurance
boolean
C2029812 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Complications Associated with Hypertensive disease | Cardiovascular Diseases | Myocardial Infarction | Cerebrovascular accident | Coronary heart disease
Item
complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ...
boolean
C0009566 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0010068 (UMLS CUI [5])
Hypertensive disease Associated with Heart Diseases
Item
arterial hypertension associated with cardiopathy
boolean
C0020538 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
Hypertensive disease Associated with Kidney Diseases
Item
arterial hypertension associated with nephropathy
boolean
C0020538 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0022658 (UMLS CUI [1,3])
Hypertensive disease Associated with Diabetes Mellitus
Item
arterial hypertension associated with diabetes
boolean
C0020538 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Measurement of systemic arterial pressure Tonometry Unsuccessful
Item
measure of central arterial pressure by tonometry is impossible
boolean
C0199663 (UMLS CUI [1,1])
C0040420 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Echogenicity cardiac Unsatisfactory
Item
cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis
boolean
C1719852 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,3])
Informed Consent Refused
Item
patient refuses informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Follow-up Unsuccessful
Item
follow-up impossible for 15 weeks
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Pregnancy | Gender Contraceptive methods Absent
Item
pregnant or women without efficacy contraception
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Patients Deprivation Freedom
Item
patient without freedom by administration decision
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
Patients Exclusion Period
Item
patient in exclusion period
boolean
C0030705 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Health Insurance french Lacking
Item
patient without french insurance
boolean
C0021682 (UMLS CUI [1,1])
C1556084 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Protection of patient Legal
Item
adult protected by the law
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
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