ID

17687

Description

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

Link

https://clinicaltrials.gov/show/NCT00229242

Keywords

Versions (1)
  1. 9/28/16 9/28/16 -
Uploaded on

September 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00229242

English

Eligibility Hypertension NCT00229242

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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;
Description

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

Data type

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;
Description

Systolic Pressure Office

Data type

boolean

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

Informed Consent

Data type

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.
Description

tolerance Hydrochlorothiazide U/day | tolerance Amlodipine U/day

Data type

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
Description

Exclusion Criteria

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

Secondary hypertension

Data type

boolean

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

Hypertensive disease | Systolic Pressure | Pharmaceutical Preparations Quantity

Data type

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;
Description

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

Data type

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;
Description

Left ventricular ejection fraction | left ventricle dimension end systolic

Data type

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;
Description

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

Data type

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;
Description

Regional left ventricular wall motion abnormality

Data type

boolean

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

Calcium Channel Blockers | Diuretics

Data type

boolean

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

24-hour ambulatory blood pressure monitoring Normal

Data type

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;
Description

Physical disability Excludes 6-minute walk test | Arthritis

Data type

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;
Description

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

Data type

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).
Description

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

Data type

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
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Similar models

Eligibility Hypertension NCT00229242

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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