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ID

17687

Beskrivning

Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures; ODM derived from: https://clinicaltrials.gov/show/NCT00229242

Länk

https://clinicaltrials.gov/show/NCT00229242

Nyckelord

  1. 2016-09-28 2016-09-28 -
Uppladdad den

28 september 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Hypertension NCT00229242

    Eligibility Hypertension NCT00229242

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 20-65 years;
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. hypertension with average 24-hour bp of >130 mmhg systolic or >80 mmhg diastolic in spite of treatment with one medication;
    Beskrivning

    Hypertensive disease | Systolic Pressure 24 hour blood pressure Average | Diastolic blood pressure 24 hour blood pressure Average | Pharmacotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2,1]
    C0871470
    UMLS CUI [2,2]
    C1282173
    UMLS CUI [2,3]
    C1510992
    UMLS CUI [3,1]
    C0428883
    UMLS CUI [3,2]
    C1282173
    UMLS CUI [3,3]
    C1510992
    UMLS CUI [4]
    C0013216
    3. office systolic blood pressure >140 mmhg and less than 180mmhg;
    Beskrivning

    Systolic Pressure Office

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0031834
    4. able to comprehend and sign the consent form;
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    5. able to tolerate either hydrochlorothiazide 25 mg or amlodipine 5 mg daily for 3 weeks during the run-in phase.
    Beskrivning

    tolerance Hydrochlorothiazide U/day | tolerance Amlodipine U/day

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0231197
    UMLS CUI [1,2]
    C0020261
    UMLS CUI [1,3]
    C0456683
    UMLS CUI [2,1]
    C0231197
    UMLS CUI [2,2]
    C0051696
    UMLS CUI [2,3]
    C0456683
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. diagnosis of secondary hypertension;
    Beskrivning

    Secondary hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0155616
    2. hypertension with systolic bp >180 mmhg in spite of 1 medication;
    Beskrivning

    Hypertensive disease | Systolic Pressure | Pharmaceutical Preparations Quantity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2]
    C0871470
    UMLS CUI [3,1]
    C0013227
    UMLS CUI [3,2]
    C1265611
    3. chronic heart failure requiring diuretics, angina or coronary syndrome requiring anti-angina therapy with ccb or beta blockers, or more than 0.4 mg/hr nitroglycerine patch;
    Beskrivning

    Chronic heart failure Requirement Diuretics | Angina Pectoris Requirement Antianginal therapy | Acute Coronary Syndrome Requirement Antianginal therapy | Calcium Channel Blockers | Adrenergic beta-Antagonists | Nitroglycerin Patch

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0264716
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0012798
    UMLS CUI [2,1]
    C0002962
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0585942
    UMLS CUI [3,1]
    C0948089
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0585942
    UMLS CUI [4]
    C0006684
    UMLS CUI [5]
    C0001645
    UMLS CUI [6,1]
    C0017887
    UMLS CUI [6,2]
    C1706366
    4. left ventricular ejection fraction (lvef) <20% or lv end systolic dimension >75 mm;
    Beskrivning

    Left ventricular ejection fraction | left ventricle dimension end systolic

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2,1]
    C2022579
    UMLS CUI [2,2]
    C0489485
    5. significant valvular disease such as; more than mild disease of aortic or mitral valve;
    Beskrivning

    Valvular disease Significant | Aortic valve disorder Moderate to severe | Disease of mitral valve Moderate to severe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3258293
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C1260873
    UMLS CUI [2,2]
    C1299393
    UMLS CUI [3,1]
    C0026265
    UMLS CUI [3,2]
    C1299393
    6. technically sub-optimal acoustic window or regional wall motion abnormalities;
    Beskrivning

    Regional left ventricular wall motion abnormality

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C4022789
    7. patients currently on both ccb and diuretics for more than 4 weeks;
    Beskrivning

    Calcium Channel Blockers | Diuretics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006684
    UMLS CUI [2]
    C0012798
    8. normal 24 hour abpm at the end of the run-in period;
    Beskrivning

    24-hour ambulatory blood pressure monitoring Normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2022220
    UMLS CUI [1,2]
    C0205307
    9. physical handicap that precludes adequate performance of 6-minute walk such as arthritis;
    Beskrivning

    Physical disability Excludes 6-minute walk test | Arthritis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0520817
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0430515
    UMLS CUI [2]
    C0003864
    10. concomitant comorbidity that might compromise ability to evaluate treatment or enhance risks of therapy, such as: atrial fibrillation with resting ventricular rate of >100 bpm; morbid obesity; uncontrolled diabetes mellitus; severe chronic obstructive pulmonary disease (copd); hypertrophic cardiomyopathy; and documented history of non-compliance with treatment;
    Beskrivning

    Comorbidity compromises Evaluation | Comorbidity Therapeutic procedure At risk | ATRIAL FIBRILLATION VENTRICULAR RATE At rest | Obesity, Morbid | Diabetic - poor control | Severe chronic obstructive pulmonary disease | Hypertrophic Cardiomyopathy | Compliance behavior Limited

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C2945640
    UMLS CUI [1,3]
    C0220825
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C1444641
    UMLS CUI [3,1]
    C0741285
    UMLS CUI [3,2]
    C0443144
    UMLS CUI [4]
    C0028756
    UMLS CUI [5]
    C0421258
    UMLS CUI [6]
    C0730607
    UMLS CUI [7]
    C0007194
    UMLS CUI [8,1]
    C1321605
    UMLS CUI [8,2]
    C0439801
    11. any condition or disorder other than hypertension that: requires prolonged hospitalization; may limit life expectancy within 2 years; would increase the risk of participation to the subject (in the opinion of the investigator).
    Beskrivning

    medical condition Requirement prolonged hospitalization | medical condition Limiting Life Expectancy | medical condition Study Subject Participation Status At risk | Hypertensive disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0745041
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C0023671
    UMLS CUI [3,1]
    C3843040
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C1444641
    UMLS CUI [4]
    C0020538

    Similar models

    Eligibility Hypertension NCT00229242

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age 20-65 years;
    boolean
    C0001779 (UMLS CUI [1])
    Hypertensive disease | Systolic Pressure 24 hour blood pressure Average | Diastolic blood pressure 24 hour blood pressure Average | Pharmacotherapy
    Item
    2. hypertension with average 24-hour bp of >130 mmhg systolic or >80 mmhg diastolic in spite of treatment with one medication;
    boolean
    C0020538 (UMLS CUI [1])
    C0871470 (UMLS CUI [2,1])
    C1282173 (UMLS CUI [2,2])
    C1510992 (UMLS CUI [2,3])
    C0428883 (UMLS CUI [3,1])
    C1282173 (UMLS CUI [3,2])
    C1510992 (UMLS CUI [3,3])
    C0013216 (UMLS CUI [4])
    Systolic Pressure Office
    Item
    3. office systolic blood pressure >140 mmhg and less than 180mmhg;
    boolean
    C0871470 (UMLS CUI [1,1])
    C0031834 (UMLS CUI [1,2])
    Informed Consent
    Item
    4. able to comprehend and sign the consent form;
    boolean
    C0021430 (UMLS CUI [1])
    tolerance Hydrochlorothiazide U/day | tolerance Amlodipine U/day
    Item
    5. able to tolerate either hydrochlorothiazide 25 mg or amlodipine 5 mg daily for 3 weeks during the run-in phase.
    boolean
    C0231197 (UMLS CUI [1,1])
    C0020261 (UMLS CUI [1,2])
    C0456683 (UMLS CUI [1,3])
    C0231197 (UMLS CUI [2,1])
    C0051696 (UMLS CUI [2,2])
    C0456683 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Secondary hypertension
    Item
    1. diagnosis of secondary hypertension;
    boolean
    C0155616 (UMLS CUI [1])
    Hypertensive disease | Systolic Pressure | Pharmaceutical Preparations Quantity
    Item
    2. hypertension with systolic bp >180 mmhg in spite of 1 medication;
    boolean
    C0020538 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0013227 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    Chronic heart failure Requirement Diuretics | Angina Pectoris Requirement Antianginal therapy | Acute Coronary Syndrome Requirement Antianginal therapy | Calcium Channel Blockers | Adrenergic beta-Antagonists | Nitroglycerin Patch
    Item
    3. chronic heart failure requiring diuretics, angina or coronary syndrome requiring anti-angina therapy with ccb or beta blockers, or more than 0.4 mg/hr nitroglycerine patch;
    boolean
    C0264716 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0012798 (UMLS CUI [1,3])
    C0002962 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0585942 (UMLS CUI [2,3])
    C0948089 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0585942 (UMLS CUI [3,3])
    C0006684 (UMLS CUI [4])
    C0001645 (UMLS CUI [5])
    C0017887 (UMLS CUI [6,1])
    C1706366 (UMLS CUI [6,2])
    Left ventricular ejection fraction | left ventricle dimension end systolic
    Item
    4. left ventricular ejection fraction (lvef) <20% or lv end systolic dimension >75 mm;
    boolean
    C0428772 (UMLS CUI [1])
    C2022579 (UMLS CUI [2,1])
    C0489485 (UMLS CUI [2,2])
    Valvular disease Significant | Aortic valve disorder Moderate to severe | Disease of mitral valve Moderate to severe
    Item
    5. significant valvular disease such as; more than mild disease of aortic or mitral valve;
    boolean
    C3258293 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C1260873 (UMLS CUI [2,1])
    C1299393 (UMLS CUI [2,2])
    C0026265 (UMLS CUI [3,1])
    C1299393 (UMLS CUI [3,2])
    Regional left ventricular wall motion abnormality
    Item
    6. technically sub-optimal acoustic window or regional wall motion abnormalities;
    boolean
    C4022789 (UMLS CUI [1])
    Calcium Channel Blockers | Diuretics
    Item
    7. patients currently on both ccb and diuretics for more than 4 weeks;
    boolean
    C0006684 (UMLS CUI [1])
    C0012798 (UMLS CUI [2])
    24-hour ambulatory blood pressure monitoring Normal
    Item
    8. normal 24 hour abpm at the end of the run-in period;
    boolean
    C2022220 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    Physical disability Excludes 6-minute walk test | Arthritis
    Item
    9. physical handicap that precludes adequate performance of 6-minute walk such as arthritis;
    boolean
    C0520817 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0430515 (UMLS CUI [1,3])
    C0003864 (UMLS CUI [2])
    Comorbidity compromises Evaluation | Comorbidity Therapeutic procedure At risk | ATRIAL FIBRILLATION VENTRICULAR RATE At rest | Obesity, Morbid | Diabetic - poor control | Severe chronic obstructive pulmonary disease | Hypertrophic Cardiomyopathy | Compliance behavior Limited
    Item
    10. concomitant comorbidity that might compromise ability to evaluate treatment or enhance risks of therapy, such as: atrial fibrillation with resting ventricular rate of >100 bpm; morbid obesity; uncontrolled diabetes mellitus; severe chronic obstructive pulmonary disease (copd); hypertrophic cardiomyopathy; and documented history of non-compliance with treatment;
    boolean
    C0009488 (UMLS CUI [1,1])
    C2945640 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    C0741285 (UMLS CUI [3,1])
    C0443144 (UMLS CUI [3,2])
    C0028756 (UMLS CUI [4])
    C0421258 (UMLS CUI [5])
    C0730607 (UMLS CUI [6])
    C0007194 (UMLS CUI [7])
    C1321605 (UMLS CUI [8,1])
    C0439801 (UMLS CUI [8,2])
    medical condition Requirement prolonged hospitalization | medical condition Limiting Life Expectancy | medical condition Study Subject Participation Status At risk | Hypertensive disease
    Item
    11. any condition or disorder other than hypertension that: requires prolonged hospitalization; may limit life expectancy within 2 years; would increase the risk of participation to the subject (in the opinion of the investigator).
    boolean
    C3843040 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0745041 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0023671 (UMLS CUI [2,3])
    C3843040 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C1444641 (UMLS CUI [3,3])
    C0020538 (UMLS CUI [4])

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