English

Eligibility Heart Failure With Hyponatremia NCT02352285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients hospitalized due to heart failure with clinically significant hyponatremia (except hypovolemic) (defined as serum na < 125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) prior to randomization.
Description

Hospitalization Due to Heart Failure | Hyponatremia | Exception HYPONATREMIA HYPOVOLEMIC | Serum sodium measurement | Hyponatremia Resistant to Fluid restriction

Data type

boolean

Alias
UMLS CUI [1]
C3898876
UMLS CUI [2]
C0020625
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0745165
UMLS CUI [4]
C0523891
UMLS CUI [5,1]
C0020625
UMLS CUI [5,2]
C0332325
UMLS CUI [5,3]
C0204700
2. male and female patients aged ≥ 20 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. new york heart association (nyha) class iii/ⅳ
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
4. signs of extracellular volume expansion, defined as two or more of the following: jvd, peripheral edema, dyspnea or pulmonary congestion.
Description

Signs Extracellular fluid volume Increase | Jugular venous engorgement | Peripheral edema | Dyspnea | Pulmonary congestion

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0412478
UMLS CUI [1,3]
C0442805
UMLS CUI [2]
C0425687
UMLS CUI [3]
C0085649
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0242073
5. b-type natriuretic peptide (bnp) ≥ 150 pg/ml or n terminal (nt)-probnp ≥ 450 pg/ml.
Description

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant, breast feeding, or of childbearing potential who are not using acceptable contraceptive methods
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
2. patients with hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion
Description

HYPONATREMIA HYPOVOLEMIC | Hyponatremia with extracellular fluid depletion

Data type

boolean

Alias
UMLS CUI [1]
C0745165
UMLS CUI [2]
C0268815
3. patients unable to sense or respond to thirst.
Description

Esthesia Thirst Unable | Response to thirst Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0036658
UMLS CUI [1,2]
C0039971
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1154981
UMLS CUI [2,2]
C1299582
4. patients who are likely to require prolonged hospitalization for reasons other than chronic heart failure (chf)
Description

Prolonged hospitalization Required | Independent of Chronic heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0745041
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0264716
5. patients with recent prior treatment for hyponatremia
Description

Prior Therapy Hyponatremia

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0020625
6. patients with severe hyponatremia symptoms requiring immediate intervention with hypertonic saline
Description

Severe symptoms Hyponatremia | Requirement Hypertonic Saline

Data type

boolean

Alias
UMLS CUI [1,1]
C0436345
UMLS CUI [1,2]
C0020625
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0036085
7. patients with causes of neurological symptoms, which are attributable to psychological (psychoses), structural (dementia of the alzheimer's type, post-infarct dementia) or other metabolic causes
Description

Cause Neurologic Symptoms | Cause Psychological | Psychotic Disorders | Cause structural | Alzheimer's Disease | Dementia Post Infarct | Cause Metabolic

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0235031
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205486
UMLS CUI [3]
C0033975
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0678594
UMLS CUI [5]
C0002395
UMLS CUI [6,1]
C0497327
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C0021308
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C0311400
8. patients with acute and transient hyponatremia associated with head trauma or severe neurological injury
Description

Hyponatremia Associated with Craniocerebral Trauma | Hyponatremia Transient Associated with Craniocerebral Trauma | Hyponatremia Associated with Neurological injury | Hyponatremia Transient Associated with Neurological injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018674
UMLS CUI [2,1]
C0020625
UMLS CUI [2,2]
C0205374
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0018674
UMLS CUI [3,1]
C0020625
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0751792
UMLS CUI [4,1]
C0020625
UMLS CUI [4,2]
C0205374
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0751792
9. patients with a history of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency.
Description

Hyponatremia Due to Hypothyroidism Severe | Hyponatremia Due to Adrenal insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0020676
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0020625
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0001623
UMLS CUI [2,4]
C0205082
10. patients with psychogenic polydipsia.
Description

Psychogenic polydipsia

Data type

boolean

Alias
UMLS CUI [1]
C0395005
11. patients with systolic bp < 90 mmhg at screening.
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
12. patients with a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan.
Description

Hypersensitivity Benzazepines | Idiosyncratic reaction Benzazepines | Hypersensitivity Benzazepine Derivative | Idiosyncratic reaction Benzazepine Derivative | Hypersensitivity Benazepril | Idiosyncratic reaction Benazepril | Hypersensitivity Tolvaptan | Idiosyncratic reaction Tolvaptan

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005034
UMLS CUI [2,1]
C0745213
UMLS CUI [2,2]
C0005034
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0005034
UMLS CUI [3,3]
C1527240
UMLS CUI [4,1]
C0745213
UMLS CUI [4,2]
C0005034
UMLS CUI [4,3]
C1527240
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0053091
UMLS CUI [6,1]
C0745213
UMLS CUI [6,2]
C0053091
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C1176308
UMLS CUI [8,1]
C0745213
UMLS CUI [8,2]
C1176308
13. patients with a history of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse.
Description

Substance Use Disorders | Medication abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0260268
14. patients with uncontrolled diabetes mellitus
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
15. patients with a current urinary tract obstruction
Description

Urinary tract obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0178879
16. anuric patients.
Description

Anuria

Data type

boolean

Alias
UMLS CUI [1]
C0003460
17. patients with a serum creatinine > 3.5 mg/dl at screening.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
18. terminally ill patients or patients with a moribund condition who have little chance of short-term survival.
Description

Terminal illness | Patient Moribund | Survival short-term Unlikely

Data type

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0424547
UMLS CUI [3,1]
C0038952
UMLS CUI [3,2]
C0443303
UMLS CUI [3,3]
C0750558
19. patients whose hyponatremia is the result of any medication that cannot safely be withdrawn, such as anti-convulsants and anti psychotics
Description

Hyponatremia Resulting from Pharmaceutical Preparations | Pharmaceutical Preparations Withdraw Unsuccessful | Anticonvulsants | Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2349954
UMLS CUI [2,3]
C1272705
UMLS CUI [3]
C0003286
UMLS CUI [4]
C0040615
20. patients receiving desmopressin within 2 days of screening.
Description

desmopressin

Data type

boolean

Alias
UMLS CUI [1]
C0011701
21. patients who have participated in another investigational drug trial within the past 30 days.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
22. any patient who, in the opinion of the investigator, would not be able to comply with the study drug administration or study procedures, or whose overall medical condition would prohibit their participation in the study.
Description

Protocol Compliance Unable | Medical condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
23. patients treated and/or to be treated with strong cytochrome p450 (cyp) 3a inhibitors
Description

CYP3A Inhibitors Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
24. patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose- galactose malabsorption.
Description

Galactosemia Hereditary | Lapps Lactase deficiency Hereditary | Congenital glucose-galactose malabsorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0016952
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0337904
UMLS CUI [2,2]
C0302813
UMLS CUI [2,3]
C0439660
UMLS CUI [3]
C0268186
25. patients with a ast or alt > uln 2.5 or total bilirubin > 2mg/dl
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C1278039
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Similar models

Eligibility Heart Failure With Hyponatremia NCT02352285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Due to Heart Failure | Hyponatremia | Exception HYPONATREMIA HYPOVOLEMIC | Serum sodium measurement | Hyponatremia Resistant to Fluid restriction
Item
1. patients hospitalized due to heart failure with clinically significant hyponatremia (except hypovolemic) (defined as serum na < 125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) prior to randomization.
boolean
C3898876 (UMLS CUI [1])
C0020625 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0745165 (UMLS CUI [3,2])
C0523891 (UMLS CUI [4])
C0020625 (UMLS CUI [5,1])
C0332325 (UMLS CUI [5,2])
C0204700 (UMLS CUI [5,3])
Age
Item
2. male and female patients aged ≥ 20 years.
boolean
C0001779 (UMLS CUI [1])
New York Heart Association Classification
Item
3. new york heart association (nyha) class iii/ⅳ
boolean
C1275491 (UMLS CUI [1])
Signs Extracellular fluid volume Increase | Jugular venous engorgement | Peripheral edema | Dyspnea | Pulmonary congestion
Item
4. signs of extracellular volume expansion, defined as two or more of the following: jvd, peripheral edema, dyspnea or pulmonary congestion.
boolean
C0311392 (UMLS CUI [1,1])
C0412478 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0425687 (UMLS CUI [2])
C0085649 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0242073 (UMLS CUI [5])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
5. b-type natriuretic peptide (bnp) ≥ 150 pg/ml or n terminal (nt)-probnp ≥ 450 pg/ml.
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
1. women who are pregnant, breast feeding, or of childbearing potential who are not using acceptable contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
HYPONATREMIA HYPOVOLEMIC | Hyponatremia with extracellular fluid depletion
Item
2. patients with hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion
boolean
C0745165 (UMLS CUI [1])
C0268815 (UMLS CUI [2])
Esthesia Thirst Unable | Response to thirst Unable
Item
3. patients unable to sense or respond to thirst.
boolean
C0036658 (UMLS CUI [1,1])
C0039971 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1154981 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Prolonged hospitalization Required | Independent of Chronic heart failure
Item
4. patients who are likely to require prolonged hospitalization for reasons other than chronic heart failure (chf)
boolean
C0745041 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0332291 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
Prior Therapy Hyponatremia
Item
5. patients with recent prior treatment for hyponatremia
boolean
C1514463 (UMLS CUI [1,1])
C0020625 (UMLS CUI [1,2])
Severe symptoms Hyponatremia | Requirement Hypertonic Saline
Item
6. patients with severe hyponatremia symptoms requiring immediate intervention with hypertonic saline
boolean
C0436345 (UMLS CUI [1,1])
C0020625 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0036085 (UMLS CUI [2,2])
Cause Neurologic Symptoms | Cause Psychological | Psychotic Disorders | Cause structural | Alzheimer's Disease | Dementia Post Infarct | Cause Metabolic
Item
7. patients with causes of neurological symptoms, which are attributable to psychological (psychoses), structural (dementia of the alzheimer's type, post-infarct dementia) or other metabolic causes
boolean
C0015127 (UMLS CUI [1,1])
C0235031 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0205486 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3])
C0015127 (UMLS CUI [4,1])
C0678594 (UMLS CUI [4,2])
C0002395 (UMLS CUI [5])
C0497327 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0021308 (UMLS CUI [6,3])
C0015127 (UMLS CUI [7,1])
C0311400 (UMLS CUI [7,2])
Hyponatremia Associated with Craniocerebral Trauma | Hyponatremia Transient Associated with Craniocerebral Trauma | Hyponatremia Associated with Neurological injury | Hyponatremia Transient Associated with Neurological injury
Item
8. patients with acute and transient hyponatremia associated with head trauma or severe neurological injury
boolean
C0020625 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018674 (UMLS CUI [1,3])
C0020625 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0018674 (UMLS CUI [2,4])
C0020625 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0751792 (UMLS CUI [3,3])
C0020625 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0751792 (UMLS CUI [4,4])
Hyponatremia Due to Hypothyroidism Severe | Hyponatremia Due to Adrenal insufficiency Severe
Item
9. patients with a history of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency.
boolean
C0020625 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0020676 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0020625 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0001623 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Psychogenic polydipsia
Item
10. patients with psychogenic polydipsia.
boolean
C0395005 (UMLS CUI [1])
Systolic Pressure
Item
11. patients with systolic bp < 90 mmhg at screening.
boolean
C0871470 (UMLS CUI [1])
Hypersensitivity Benzazepines | Idiosyncratic reaction Benzazepines | Hypersensitivity Benzazepine Derivative | Idiosyncratic reaction Benzazepine Derivative | Hypersensitivity Benazepril | Idiosyncratic reaction Benazepril | Hypersensitivity Tolvaptan | Idiosyncratic reaction Tolvaptan
Item
12. patients with a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan.
boolean
C0020517 (UMLS CUI [1,1])
C0005034 (UMLS CUI [1,2])
C0745213 (UMLS CUI [2,1])
C0005034 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
C0745213 (UMLS CUI [4,1])
C0005034 (UMLS CUI [4,2])
C1527240 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0053091 (UMLS CUI [5,2])
C0745213 (UMLS CUI [6,1])
C0053091 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C1176308 (UMLS CUI [7,2])
C0745213 (UMLS CUI [8,1])
C1176308 (UMLS CUI [8,2])
Substance Use Disorders | Medication abuse
Item
13. patients with a history of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
C0260268 (UMLS CUI [2])
Diabetic - poor control
Item
14. patients with uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Urinary tract obstruction
Item
15. patients with a current urinary tract obstruction
boolean
C0178879 (UMLS CUI [1])
Anuria
Item
16. anuric patients.
boolean
C0003460 (UMLS CUI [1])
Creatinine measurement, serum
Item
17. patients with a serum creatinine > 3.5 mg/dl at screening.
boolean
C0201976 (UMLS CUI [1])
Terminal illness | Patient Moribund | Survival short-term Unlikely
Item
18. terminally ill patients or patients with a moribund condition who have little chance of short-term survival.
boolean
C0679247 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0424547 (UMLS CUI [2,2])
C0038952 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
Hyponatremia Resulting from Pharmaceutical Preparations | Pharmaceutical Preparations Withdraw Unsuccessful | Anticonvulsants | Antipsychotic Agents
Item
19. patients whose hyponatremia is the result of any medication that cannot safely be withdrawn, such as anti-convulsants and anti psychotics
boolean
C0020625 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0003286 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
desmopressin
Item
20. patients receiving desmopressin within 2 days of screening.
boolean
C0011701 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
21. patients who have participated in another investigational drug trial within the past 30 days.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unable | Medical condition Study Subject Participation Status Excluded
Item
22. any patient who, in the opinion of the investigator, would not be able to comply with the study drug administration or study procedures, or whose overall medical condition would prohibit their participation in the study.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
CYP3A Inhibitors Strong
Item
23. patients treated and/or to be treated with strong cytochrome p450 (cyp) 3a inhibitors
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Galactosemia Hereditary | Lapps Lactase deficiency Hereditary | Congenital glucose-galactose malabsorption
Item
24. patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose- galactose malabsorption.
boolean
C0016952 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0337904 (UMLS CUI [2,1])
C0302813 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
C0268186 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum total bilirubin measurement
Item
25. patients with a ast or alt > uln 2.5 or total bilirubin > 2mg/dl
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
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