ID

40111

Description

A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01658657

Link

https://clinicaltrials.gov/show/NCT01658657

Keywords

Versions (1)
  1. 3/12/20 3/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01658657

English

Eligibility Hypertension NCT01658657

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
systolic bp average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmhg, or diastolic bp average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmhg
Description

Systolic Pressure Average | Diastolic blood pressure Average | Clinic Visits Quantity | Emergency department visit Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C1510992
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0586082
UMLS CUI [4,2]
C1265611
not currently taking bp-lowering medication
Description

Antihypertensive Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
clinician recommends pharmacologic treatment
Description

Clinician Recommendation Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0871685
UMLS CUI [1,2]
C0034866
UMLS CUI [1,3]
C0013216
willing to make necessary study visits
Description

Clinical Trial Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1512346
able to be contacted by phone
Description

Patient contacted by Telephone

Data type

boolean

Alias
UMLS CUI [1,1]
C2051442
UMLS CUI [1,2]
C0039457
has a primary care clinician
Description

Primary Care Physician Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0033131
UMLS CUI [1,2]
C0470187
at least 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known secondary cause of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
known diabetes, coronary artery disease or renal disease
Description

Diabetes Mellitus | Coronary Artery Disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0022658
known sulfonamide allergy or history of gout
Description

Allergy to sulfonamides | Gout

Data type

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2]
C0018099
participant's clinician recommends he/she not enroll
Description

Study Subject Participation Status | Clinician Recommendation Refusal to Participate

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0871685
UMLS CUI [2,2]
C0034866
UMLS CUI [2,3]
C1136454
hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
Description

Hyponatremia | Hypokalemia | Hypernatremia | Hyperglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0020625
UMLS CUI [2]
C0020621
UMLS CUI [3]
C0020488
UMLS CUI [4]
C0020456
baseline visit systolic visit bp average < 140 mmhg and diastolic bp average < 90 mm hg
Description

Systolic Pressure Average | Diastolic blood pressure Average

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C1510992
resting heart rate < 55 beats per minute
Description

RESTING HEART RATE

Data type

boolean

Alias
UMLS CUI [1]
C1821417
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Similar models

Eligibility Hypertension NCT01658657

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure Average | Diastolic blood pressure Average | Clinic Visits Quantity | Emergency department visit Quantity
Item
systolic bp average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmhg, or diastolic bp average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0586082 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Antihypertensive Agents Absent
Item
not currently taking bp-lowering medication
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Clinician Recommendation Pharmacotherapy
Item
clinician recommends pharmacologic treatment
boolean
C0871685 (UMLS CUI [1,1])
C0034866 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Clinical Trial Visits
Item
willing to make necessary study visits
boolean
C0008976 (UMLS CUI [1,1])
C1512346 (UMLS CUI [1,2])
Patient contacted by Telephone
Item
able to be contacted by phone
boolean
C2051442 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
Primary Care Physician Available
Item
has a primary care clinician
boolean
C0033131 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
known secondary cause of hypertension
boolean
C0155616 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Diabetes Mellitus | Coronary Artery Disease | Kidney Disease
Item
known diabetes, coronary artery disease or renal disease
boolean
C0011849 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
Allergy to sulfonamides | Gout
Item
known sulfonamide allergy or history of gout
boolean
C0038757 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
Study Subject Participation Status | Clinician Recommendation Refusal to Participate
Item
participant's clinician recommends he/she not enroll
boolean
C2348568 (UMLS CUI [1])
C0871685 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C1136454 (UMLS CUI [2,3])
Hyponatremia | Hypokalemia | Hypernatremia | Hyperglycemia
Item
hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
boolean
C0020625 (UMLS CUI [1])
C0020621 (UMLS CUI [2])
C0020488 (UMLS CUI [3])
C0020456 (UMLS CUI [4])
Systolic Pressure Average | Diastolic blood pressure Average
Item
baseline visit systolic visit bp average < 140 mmhg and diastolic bp average < 90 mm hg
boolean
C0871470 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
RESTING HEART RATE
Item
resting heart rate < 55 beats per minute
boolean
C1821417 (UMLS CUI [1])
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