ID

20793

Description

Pharmacosurveillance and Pharmacogenetics of First-line Diuretics in Hypertension: The StayOnDiur Study; ODM derived from: https://clinicaltrials.gov/show/NCT00408512

Lien

https://clinicaltrials.gov/show/NCT00408512

Mots-clés

Versions (1)
  1. 18/03/2017 18/03/2017 -
Téléchargé le

18 mars 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00408512

Anglais

Eligibility Essential Hypertension NCT00408512

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hypertensive patients will be 18 to 75-year old.
Description

Hypertensive disease | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0001779
eligible patients will be asked for written informed consent and thereafter referred to the identified hypertension specialist centre located in their areas, for end-organ damage evaluation by echocardiography, carotid ultrasound and urine dip-stick.
Description

Informed Consent | End organ damage Evaluation | Echocardiography | Carotid artery ultrasound | Urine dipstick test

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0743496
UMLS CUI [2,2]
C1261322
UMLS CUI [3]
C0013516
UMLS CUI [4]
C0948945
UMLS CUI [5]
C0430370
eligible patients are required to have stage ic or ii essential hypertension, and to be previously untreated or poorly controlled. they will be selected by gps participating into the study. similar to untreated patients, those with poor control of blood pressure under multiple-drug therapy will start treatment with one single drug, which will be titrated to the highest dose before adding subsequent medications, based on the gp's judgement.
Description

Hypertensive disease stage | Hypertension untreated | Poor hypertension control | Study Subject Participation Status | Pharmaceutical Preparation Single High dose | Pharmaceutical Preparations multiple

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
UMLS CUI [2]
C0745134
UMLS CUI [3]
C0421190
UMLS CUI [4]
C2348568
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0205171
UMLS CUI [5,3]
C0444956
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0439064
hypertension will be defined according to 2003 esh/esc guidelines (1). blood and urine tests will be performed, according to guidelines for hypertension management for general practitioners (gp) of the regione campania (see burc number 11, 18/02/2002). this screening includes cell blood counts (cbcs), serum creatinine, sodium, potassium, uric acid, total cholesterol, triglycerides, hdl-cholesterol, glucose, urine analysis and ekg. ldl will be calculated starting from the total cholesterol, triglyceride and hdl-cholesterol.
Description

Hypertensive disease | Hematologic Tests | Urinalysis | Blood Cell Count | Creatinine measurement, serum | Sodium measurement | Potassium measurement | Uric acid measurement | Serum total cholesterol measurement | Triglycerides measurement | Serum HDL cholesterol measurement | Glucose measurement | Electrocardiography

Type de données

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0042014
UMLS CUI [4]
C0005771
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0337443
UMLS CUI [7]
C0202194
UMLS CUI [8]
C0202239
UMLS CUI [9]
C1445957
UMLS CUI [10]
C0202236
UMLS CUI [11]
C0428472
UMLS CUI [12]
C0337438
UMLS CUI [13]
C1623258
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
omen in fertile age not using recognized contraceptive methods, or pregnant or nursing will be excluded from the protocol, since the use of many antihypertensive drugs is contraindicated in pregnancy and lactation.
Description

Childbearing Potential Contraceptive methods Missing | Pregnancy | Breast Feeding | Medical contraindication Antihypertensive Agents many

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1705492
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0003364
UMLS CUI [4,3]
C0439064
patients will be excluded when presenting with documented coronary or cerebrovascular events in the previous 6 months, nyha class higher than 1
Description

Heart Event New York Heart Association Classification | Event Cerebrovascular New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1880018
UMLS CUI [2,3]
C1275491
history of congestive heart failure
Description

Congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C0018802
secondary hypertension
Description

Secondary hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C0155616
cancer disease
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
renal disease (serum creatinine >2 mg/dl)
Description

Kidney Diseases | Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
liver cirrhosis or severe dysfunction, or any other health problem that may interfere with the projected 2 year follow-up.
Description

Liver Cirrhosis | Liver Dysfunction Severe | Health Problem Interferes with Clinical Study Follow-up

Type de données

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0018684
UMLS CUI [3,2]
C0033213
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C3274571
data will be stored in an electronic database located in the coordinating centre, to which gps may have access for uploading data on a daily base, using personal, encrypted, login and password. these data will be stored in the central database. after local echocardiographic evaluation, patients showing left ventricular ejection fraction < 45% will be excluded from the study.
Description

Data Storage Database | Echocardiography Evaluation | Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242578
UMLS CUI [1,2]
C0242356
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C1261322
UMLS CUI [3]
C0428772
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Similar models

Eligibility Essential Hypertension NCT00408512

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Age
Item
hypertensive patients will be 18 to 75-year old.
boolean
C0020538 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent | End organ damage Evaluation | Echocardiography | Carotid artery ultrasound | Urine dipstick test
Item
eligible patients will be asked for written informed consent and thereafter referred to the identified hypertension specialist centre located in their areas, for end-organ damage evaluation by echocardiography, carotid ultrasound and urine dip-stick.
boolean
C0021430 (UMLS CUI [1])
C0743496 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0013516 (UMLS CUI [3])
C0948945 (UMLS CUI [4])
C0430370 (UMLS CUI [5])
Hypertensive disease stage | Hypertension untreated | Poor hypertension control | Study Subject Participation Status | Pharmaceutical Preparation Single High dose | Pharmaceutical Preparations multiple
Item
eligible patients are required to have stage ic or ii essential hypertension, and to be previously untreated or poorly controlled. they will be selected by gps participating into the study. similar to untreated patients, those with poor control of blood pressure under multiple-drug therapy will start treatment with one single drug, which will be titrated to the highest dose before adding subsequent medications, based on the gp's judgement.
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0745134 (UMLS CUI [2])
C0421190 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C0444956 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0439064 (UMLS CUI [6,2])
Hypertensive disease | Hematologic Tests | Urinalysis | Blood Cell Count | Creatinine measurement, serum | Sodium measurement | Potassium measurement | Uric acid measurement | Serum total cholesterol measurement | Triglycerides measurement | Serum HDL cholesterol measurement | Glucose measurement | Electrocardiography
Item
hypertension will be defined according to 2003 esh/esc guidelines (1). blood and urine tests will be performed, according to guidelines for hypertension management for general practitioners (gp) of the regione campania (see burc number 11, 18/02/2002). this screening includes cell blood counts (cbcs), serum creatinine, sodium, potassium, uric acid, total cholesterol, triglycerides, hdl-cholesterol, glucose, urine analysis and ekg. ldl will be calculated starting from the total cholesterol, triglyceride and hdl-cholesterol.
boolean
C0020538 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0042014 (UMLS CUI [3])
C0005771 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0337443 (UMLS CUI [6])
C0202194 (UMLS CUI [7])
C0202239 (UMLS CUI [8])
C1445957 (UMLS CUI [9])
C0202236 (UMLS CUI [10])
C0428472 (UMLS CUI [11])
C0337438 (UMLS CUI [12])
C1623258 (UMLS CUI [13])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Missing | Pregnancy | Breast Feeding | Medical contraindication Antihypertensive Agents many
Item
omen in fertile age not using recognized contraceptive methods, or pregnant or nursing will be excluded from the protocol, since the use of many antihypertensive drugs is contraindicated in pregnancy and lactation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0003364 (UMLS CUI [4,2])
C0439064 (UMLS CUI [4,3])
Heart Event New York Heart Association Classification | Event Cerebrovascular New York Heart Association Classification
Item
patients will be excluded when presenting with documented coronary or cerebrovascular events in the previous 6 months, nyha class higher than 1
boolean
C0018787 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0441471 (UMLS CUI [2,1])
C1880018 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Congestive heart failure
Item
history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Malignant Neoplasms
Item
cancer disease
boolean
C0006826 (UMLS CUI [1])
Kidney Diseases | Creatinine measurement, serum
Item
renal disease (serum creatinine >2 mg/dl)
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver Cirrhosis | Liver Dysfunction Severe | Health Problem Interferes with Clinical Study Follow-up
Item
liver cirrhosis or severe dysfunction, or any other health problem that may interfere with the projected 2 year follow-up.
boolean
C0023890 (UMLS CUI [1])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018684 (UMLS CUI [3,1])
C0033213 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C3274571 (UMLS CUI [3,4])
Data Storage Database | Echocardiography Evaluation | Left ventricular ejection fraction
Item
data will be stored in an electronic database located in the coordinating centre, to which gps may have access for uploading data on a daily base, using personal, encrypted, login and password. these data will be stored in the central database. after local echocardiographic evaluation, patients showing left ventricular ejection fraction < 45% will be excluded from the study.
boolean
C0242578 (UMLS CUI [1,1])
C0242356 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
Retour au début de la page 

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