ID

29266

Description

Aliskiren and Renin Inhibition in Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00773084

Link

https://clinicaltrials.gov/show/NCT00773084

Keywords

Versions (1)
  1. 3/14/18 3/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diastolic Heart Failure NCT00773084

English

Eligibility Diastolic Heart Failure NCT00773084

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chronic stable diastolic hf documented by clinical diagnosis and echocardiogram within the last 2 years
Description

Chronic diastolic heart failure Stable Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C2711480
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0013516
2. nyha classes i-iii, symptomatically stable (for >1month)
Description

Disease Symptomatic Stable New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C1275491
3. age 21-70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. either of hispanic ethnicity (mexican american origin) or non-hispanic white
Description

Hispanics | Mexican Americans | Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0086409
UMLS CUI [2]
C0025884
UMLS CUI [3]
C0043157
5. patients on ace inhibitor therapy (lisinopril)
Description

Angiotensin-Converting Enzyme Inhibitors | Lisinopril

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0065374
6. blood pressure >100/75 mmhg
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
7. adequate birth control
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
8. patients seen in ttuhsc cardiology or internal medicine clinic for at least two visits since january 2008
Description

Patient Visit Quantity Cardiology department | Patient Visit Quantity Internal medicine clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0587453
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C3838887
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute coronary syndrome (within the last month).
Description

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
2. recent acute diastolic or systolic hf (within the last month)
Description

Heart Failure, Diastolic | Heart Failure, Systolic

Data type

boolean

Alias
UMLS CUI [1]
C1135196
UMLS CUI [2]
C1135191
3. pancreatic disease
Description

Pancreatic Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030286
4. renal artery stenosis
Description

Renal Artery Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0035067
5. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
6. history of angioedema
Description

Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0002994
7. severe hypotension (systolic bp<90mmhg or mean arterial pressure <65mmhg)
Description

Hypotension, severe | Systolic Pressure | Mean arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C2678378
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428886
8. hyperkalemia (defined by k+>5 meq/l)
Description

Hyperkalemia

Data type

boolean

Alias
UMLS CUI [1]
C0020461
9. chronic kidney disease (stage 3 and above)
Description

Chronic Kidney Disease Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
10. systolic dysfunction (ejection fraction below 50%)
Description

Systolic dysfunction | Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0749225
UMLS CUI [2]
C0232174
11. ethnicity other than mexican american or non-hispanic white
Description

Ethnic group | Exception Mexican Americans | Exception Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025884
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0043157
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Similar models

Eligibility Diastolic Heart Failure NCT00773084

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic diastolic heart failure Stable Echocardiography
Item
1. chronic stable diastolic hf documented by clinical diagnosis and echocardiogram within the last 2 years
boolean
C2711480 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Disease Symptomatic Stable New York Heart Association Classification
Item
2. nyha classes i-iii, symptomatically stable (for >1month)
boolean
C0012634 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1275491 (UMLS CUI [1,4])
Age
Item
3. age 21-70 years
boolean
C0001779 (UMLS CUI [1])
Hispanics | Mexican Americans | Caucasians
Item
4. either of hispanic ethnicity (mexican american origin) or non-hispanic white
boolean
C0086409 (UMLS CUI [1])
C0025884 (UMLS CUI [2])
C0043157 (UMLS CUI [3])
Angiotensin-Converting Enzyme Inhibitors | Lisinopril
Item
5. patients on ace inhibitor therapy (lisinopril)
boolean
C0003015 (UMLS CUI [1])
C0065374 (UMLS CUI [2])
Blood pressure determination
Item
6. blood pressure >100/75 mmhg
boolean
C0005824 (UMLS CUI [1])
Contraceptive methods
Item
7. adequate birth control
boolean
C0700589 (UMLS CUI [1])
Patient Visit Quantity Cardiology department | Patient Visit Quantity Internal medicine clinic
Item
8. patients seen in ttuhsc cardiology or internal medicine clinic for at least two visits since january 2008
boolean
C1512346 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0587453 (UMLS CUI [1,3])
C1512346 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3838887 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome
Item
1. acute coronary syndrome (within the last month).
boolean
C0948089 (UMLS CUI [1])
Heart Failure, Diastolic | Heart Failure, Systolic
Item
2. recent acute diastolic or systolic hf (within the last month)
boolean
C1135196 (UMLS CUI [1])
C1135191 (UMLS CUI [2])
Pancreatic Disease
Item
3. pancreatic disease
boolean
C0030286 (UMLS CUI [1])
Renal Artery Stenosis
Item
4. renal artery stenosis
boolean
C0035067 (UMLS CUI [1])
Pregnancy
Item
5. pregnancy
boolean
C0032961 (UMLS CUI [1])
Angioedema
Item
6. history of angioedema
boolean
C0002994 (UMLS CUI [1])
Hypotension, severe | Systolic Pressure | Mean arterial pressure
Item
7. severe hypotension (systolic bp<90mmhg or mean arterial pressure <65mmhg)
boolean
C2678378 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428886 (UMLS CUI [3])
Hyperkalemia
Item
8. hyperkalemia (defined by k+>5 meq/l)
boolean
C0020461 (UMLS CUI [1])
Chronic Kidney Disease Stage
Item
9. chronic kidney disease (stage 3 and above)
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
Systolic dysfunction | Cardiac ejection fraction
Item
10. systolic dysfunction (ejection fraction below 50%)
boolean
C0749225 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
Ethnic group | Exception Mexican Americans | Exception Caucasians
Item
11. ethnicity other than mexican american or non-hispanic white
boolean
C0015031 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025884 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0043157 (UMLS CUI [3,2])
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