ID

39467

Descripción

The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT01663662

Link

https://clinicaltrials.gov/show/NCT01663662

Palabras clave

Versiones (1)
  1. 14/1/20 14/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01663662

Inglés

Eligibility Heart Failure NCT01663662

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
prior clinical diagnosis of systolic heart failure (ef < 40% within the past 18 months) with daily home use of oral loop diuretic for at least one month.
Descripción

Heart Failure, Systolic | Cardiac ejection fraction | Loop Diuretics Oral Daily

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C0232174
UMLS CUI [3,1]
C0354100
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332173
daily oral dose of furosemide ≥ 40 mg and ≤ 240 mg (or equivalent)
Descripción

Furosemide Oral Dose U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016860
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
identified within 24 hours of hospital admission
Descripción

Identified | Hospital admission

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205396
UMLS CUI [2]
C0184666
heart failure defined by at least 1 symptom (dyspnea, orthopnea, or edema) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
Descripción

Heart failure | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Sign Quantity | Rales Auscultation | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest X-ray

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0085619
UMLS CUI [5]
C0013604
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C1265611
UMLS CUI [7,1]
C0034642
UMLS CUI [7,2]
C0004339
UMLS CUI [8]
C0085649
UMLS CUI [9]
C0003962
UMLS CUI [10,1]
C0242073
UMLS CUI [10,2]
C1801960
UMLS CUI [10,3]
C0039985
anticipated need for iv loop diuretics for at least 48 hours
Descripción

Patient need for Loop Diuretics Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0354100
UMLS CUI [1,3]
C1522726
likely requires daily net urine output in the range of 1-3 l/day for over a 72-96 hour time period.
Descripción

Urine output U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232856
UMLS CUI [1,2]
C0456683
albumin level < 3.5 g/dl
Descripción

Albumin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201838
willingness to provide informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
received or planned iv vasoactive treatment (inotropes, vasodilators) or ultra-filtration therapy for heart failure
Descripción

Vasoactive agent Intravenous Heart failure | Vasoactive agent Intravenous Planned | Inotropic agent | Vasodilator Agents | Ultrafiltration Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0597639
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C1301732
UMLS CUI [3]
C0304509
UMLS CUI [4]
C0042402
UMLS CUI [5,1]
C0041612
UMLS CUI [5,2]
C0018801
bnp < 250 ng/ml or nt-probnp < 1000 mg/ml (if drawn for clinical purposes)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
systolic bp < 90 mmhg
Descripción

Systolic Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
serum creatinine > 3.0 mg/dl at baseline or renal replacement therapy or creatinine clearances < 10 ml/min
Descripción

Creatinine measurement, serum | Renal Replacement Therapy | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0206074
UMLS CUI [3]
C0373595
serum sodium > 145 meq/l
Descripción

Serum sodium measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0523891
acute coronary syndrome within 4 weeks
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
anticipated need for coronary angiography or other procedures requiring iv contrast.
Descripción

Patient need for Coronary angiography | Procedure Requirement Intravenous contrast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0085532
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C4072741
patients receiving any of the following drugs: clarithromycin, ketoconazole, itraconazole,ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin, erythromycin, fluconazole, aprepitant, diltiazem, verapamil, cyclosporine, and grapefruit juice.
Descripción

Clarithromycin | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Nelfinavir | Saquinavir | nefazodone | telithromycin | Erythromycin | Fluconazole | aprepitant | Diltiazem | Verapamil | Cyclosporine | GRAPEFRUIT JUICE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0055856
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0376637
UMLS CUI [6]
C0525005
UMLS CUI [7]
C0286738
UMLS CUI [8]
C0068485
UMLS CUI [9]
C0907410
UMLS CUI [10]
C0014806
UMLS CUI [11]
C0016277
UMLS CUI [12]
C1176306
UMLS CUI [13]
C0012373
UMLS CUI [14]
C0042523
UMLS CUI [15]
C0010592
UMLS CUI [16]
C0452456
pregnant or nursing patients.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Heart Failure NCT01663662

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Heart Failure, Systolic | Cardiac ejection fraction | Loop Diuretics Oral Daily
Item
prior clinical diagnosis of systolic heart failure (ef < 40% within the past 18 months) with daily home use of oral loop diuretic for at least one month.
boolean
C1135191 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
C0354100 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Furosemide Oral Dose U/day
Item
daily oral dose of furosemide ≥ 40 mg and ≤ 240 mg (or equivalent)
boolean
C0016860 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Identified | Hospital admission
Item
identified within 24 hours of hospital admission
boolean
C0205396 (UMLS CUI [1])
C0184666 (UMLS CUI [2])
Heart failure | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Sign Quantity | Rales Auscultation | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest X-ray
Item
heart failure defined by at least 1 symptom (dyspnea, orthopnea, or edema) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
boolean
C0018801 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013404 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C0013604 (UMLS CUI [5])
C0311392 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0034642 (UMLS CUI [7,1])
C0004339 (UMLS CUI [7,2])
C0085649 (UMLS CUI [8])
C0003962 (UMLS CUI [9])
C0242073 (UMLS CUI [10,1])
C1801960 (UMLS CUI [10,2])
C0039985 (UMLS CUI [10,3])
Patient need for Loop Diuretics Intravenous
Item
anticipated need for iv loop diuretics for at least 48 hours
boolean
C0686904 (UMLS CUI [1,1])
C0354100 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
Urine output U/day
Item
likely requires daily net urine output in the range of 1-3 l/day for over a 72-96 hour time period.
boolean
C0232856 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Albumin measurement
Item
albumin level < 3.5 g/dl
boolean
C0201838 (UMLS CUI [1])
Informed Consent
Item
willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vasoactive agent Intravenous Heart failure | Vasoactive agent Intravenous Planned | Inotropic agent | Vasodilator Agents | Ultrafiltration Heart failure
Item
received or planned iv vasoactive treatment (inotropes, vasodilators) or ultra-filtration therapy for heart failure
boolean
C0597639 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0597639 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0304509 (UMLS CUI [3])
C0042402 (UMLS CUI [4])
C0041612 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
bnp < 250 ng/ml or nt-probnp < 1000 mg/ml (if drawn for clinical purposes)
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Systolic Pressure
Item
systolic bp < 90 mmhg
boolean
C0871470 (UMLS CUI [1])
Creatinine measurement, serum | Renal Replacement Therapy | Creatinine clearance measurement
Item
serum creatinine > 3.0 mg/dl at baseline or renal replacement therapy or creatinine clearances < 10 ml/min
boolean
C0201976 (UMLS CUI [1])
C0206074 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Serum sodium measurement
Item
serum sodium > 145 meq/l
boolean
C0523891 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome within 4 weeks
boolean
C0948089 (UMLS CUI [1])
Patient need for Coronary angiography | Procedure Requirement Intravenous contrast
Item
anticipated need for coronary angiography or other procedures requiring iv contrast.
boolean
C0686904 (UMLS CUI [1,1])
C0085532 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C4072741 (UMLS CUI [2,3])
Clarithromycin | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Nelfinavir | Saquinavir | nefazodone | telithromycin | Erythromycin | Fluconazole | aprepitant | Diltiazem | Verapamil | Cyclosporine | GRAPEFRUIT JUICE
Item
patients receiving any of the following drugs: clarithromycin, ketoconazole, itraconazole,ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin, erythromycin, fluconazole, aprepitant, diltiazem, verapamil, cyclosporine, and grapefruit juice.
boolean
C0055856 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0525005 (UMLS CUI [6])
C0286738 (UMLS CUI [7])
C0068485 (UMLS CUI [8])
C0907410 (UMLS CUI [9])
C0014806 (UMLS CUI [10])
C0016277 (UMLS CUI [11])
C1176306 (UMLS CUI [12])
C0012373 (UMLS CUI [13])
C0042523 (UMLS CUI [14])
C0010592 (UMLS CUI [15])
C0452456 (UMLS CUI [16])
Pregnancy | Breast Feeding
Item
pregnant or nursing patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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