ID

39486

Descripción

Studies Investigating Co-morbidities Aggravating Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01872299

Link

https://clinicaltrials.gov/show/NCT01872299

Palabras clave

Versiones (1)
  1. 16/1/20 16/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01872299

Inglés

Eligibility Heart Failure NCT01872299

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of heart failure;
Descripción

Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
objective evidence of cardiac dysfunctions as evidenced by at least one of the following:
Descripción

Cardiac dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3277906
left ventricular ejection fraction ≤ 40%;
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
left atrial dimension >4.0 cm (or >2.5 cm/m in height)
Descripción

Left atrium Dimension | Left atrium Dimension Height

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0439534
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C0489786
nt-probnp >400 pg/ml [>47.3 pmol/l] (or bnp >150 pg/ml)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C1095989
current treatment with loop diuretics;
Descripción

Loop Diuretics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0354100
age >18 years;
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
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
congenital heart disease;
Descripción

Congenital heart disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0152021
any life-threatening disease other than heart failure;
Descripción

Life threatening illness | Exception Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
active malignancy of any type, or history of a malignancy within previous 5 years;
Descripción

Malignant Neoplasm Type Any | History of malignant neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0455471
previous heart transplantation;
Descripción

Heart Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018823
intra-venous therapy for heart failure given within the previous 72 hours;
Descripción

Intravenous therapy Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455142
UMLS CUI [1,2]
C0018801
severe neuro-muscular disease;
Descripción

Neuromuscular Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027868
UMLS CUI [1,2]
C0205082
history of unstable angina, myocardial infarction or stroke within 3 months prior to the study;
Descripción

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
pregnancy;
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease;
Descripción

Therapeutic immunosuppression | Steroid therapy Rheumatoid Arthritis | Steroid therapy Obstructive Lung Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0600260
significant renal dysfunction, defined as serum creatinine >250 μmol/l [>2.8 mg/dl];
Descripción

Renal dysfunction | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
severe liver disease, defined as any liver function tests >3 times the upper limit of normal;
Descripción

Liver disease Severe | Increased liver function tests

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0877359
unable to understand and comply with protocol or to give informed consent.
Descripción

Study Protocol Comprehension Unable | Protocol Compliance Unable | Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
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Similar models

Eligibility Heart Failure NCT01872299

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
clinical diagnosis of heart failure;
boolean
C0018801 (UMLS CUI [1])
Cardiac dysfunction
Item
objective evidence of cardiac dysfunctions as evidenced by at least one of the following:
boolean
C3277906 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction ≤ 40%;
boolean
C0428772 (UMLS CUI [1])
Left atrium Dimension | Left atrium Dimension Height
Item
left atrial dimension >4.0 cm (or >2.5 cm/m in height)
boolean
C0225860 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0225860 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C0489786 (UMLS CUI [2,3])
N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement
Item
nt-probnp >400 pg/ml [>47.3 pmol/l] (or bnp >150 pg/ml)
boolean
C3272900 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
Loop Diuretics
Item
current treatment with loop diuretics;
boolean
C0354100 (UMLS CUI [1])
Age
Item
age >18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congenital heart disease
Item
congenital heart disease;
boolean
C0152021 (UMLS CUI [1])
Life threatening illness | Exception Heart failure
Item
any life-threatening disease other than heart failure;
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Malignant Neoplasm Type Any | History of malignant neoplasm
Item
active malignancy of any type, or history of a malignancy within previous 5 years;
boolean
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0455471 (UMLS CUI [2])
Heart Transplantation
Item
previous heart transplantation;
boolean
C0018823 (UMLS CUI [1])
Intravenous therapy Heart failure
Item
intra-venous therapy for heart failure given within the previous 72 hours;
boolean
C0455142 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Neuromuscular Disease Severe
Item
severe neuro-muscular disease;
boolean
C0027868 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Angina, Unstable | Myocardial Infarction | Cerebrovascular accident
Item
history of unstable angina, myocardial infarction or stroke within 3 months prior to the study;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Therapeutic immunosuppression | Steroid therapy Rheumatoid Arthritis | Steroid therapy Obstructive Lung Disease
Item
treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease;
boolean
C0021079 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0600260 (UMLS CUI [3,2])
Renal dysfunction | Creatinine measurement, serum
Item
significant renal dysfunction, defined as serum creatinine >250 μmol/l [>2.8 mg/dl];
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver disease Severe | Increased liver function tests
Item
severe liver disease, defined as any liver function tests >3 times the upper limit of normal;
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877359 (UMLS CUI [2])
Study Protocol Comprehension Unable | Protocol Compliance Unable | Informed Consent Unable
Item
unable to understand and comply with protocol or to give informed consent.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
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