ID

39489

Beschreibung

Partial Left Ventricular Support in Advanced Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01879670

Link

https://clinicaltrials.gov/show/NCT01879670

Stichworte

Versionen (1)
  1. 17.01.20 17.01.20 -
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See clinicaltrials.gov

Hochgeladen am

17. Januar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01879670

Englisch

Eligibility Heart Failure NCT01879670

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with ischaemic or dilated cardiomyopathy aged 18 to 80 years.
Beschreibung

Ischemic cardiomyopathy | Cardiomyopathy, Dilated | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0349782
UMLS CUI [2]
C0007193
UMLS CUI [3]
C0001779
symptoms categorised by intermacs (interagency registry for mechanically assisted circulatory support) at level 3-6 despite optimal tolerated medical therapy. practically this includes patients who are in hospital or managing at home with substantial dependence on hospital care.
Beschreibung

Symptoms Level | Therapy Optimal | Inpatient | Disease Management At home | Dependence Hospital care

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0441889
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
UMLS CUI [3]
C0021562
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C4534363
UMLS CUI [5,1]
C0439857
UMLS CUI [5,2]
C0259945
peak vo2 <15ml/kg/min with respiratory exchange ratio>1 on cardiopulmonary exercise testing or a 6-minute walking distance <300m or inability to perform an exercise test due to the severity of heart failure.
Beschreibung

Peak Oxygen consumption measurement | Respiratory Exchange Ratio Cardiopulmonary Exercise Test | 6-Minute Walk Test Distance | Exercise test Unable | Etiology Heart failure Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0444505
UMLS CUI [1,2]
C1305742
UMLS CUI [2,1]
C4049826
UMLS CUI [2,2]
C2959886
UMLS CUI [3,1]
C0430515
UMLS CUI [3,2]
C0012751
UMLS CUI [4,1]
C0015260
UMLS CUI [4,2]
C1299582
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0018801
UMLS CUI [5,3]
C0205082
informed consent obtained prior to entering the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
cause of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or active myocarditis
Beschreibung

Etiology Heart failure | Thyroid Disease uncorrected | Hypertrophic Cardiomyopathy | Disorder of pericardium | Amyloidosis | Myocarditis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C4072785
UMLS CUI [3]
C0007194
UMLS CUI [4]
C0265122
UMLS CUI [5]
C0002726
UMLS CUI [6]
C0027059
body surface area <1.2m2 or >2.3m2, or body mass index >32 kg/m2.
Beschreibung

Body Surface Area | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0005902
UMLS CUI [2]
C1305855
severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume in 1 second <50% of predicted.
Beschreibung

Severe chronic obstructive pulmonary disease | Percent predicted FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0730561
history of pulmonary hypertension with maintained pulmonary vascular resistance measured > 4 wood units or transpulmonary gradient >14mmhg.
Beschreibung

Pulmonary Hypertension | Pulmonary Vascular Resistance Wood units | Gradient Transpulmonary

Datentyp

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2,1]
C0456261
UMLS CUI [2,2]
C0439525
UMLS CUI [3,1]
C0812409
UMLS CUI [3,2]
C0442377
pregnancy.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
evidence of intrinsic hepatic disease defined as liver enzyme levels > 5 times the upper limit of normal within 4 days before enrolment, severe liver dysfunction, cirrhosis or portal hypertension.
Beschreibung

Liver disease intrinsic | Elevated liver enzymes level | Liver Dysfunction Severe | Liver Cirrhosis Severe | Portal Hypertension Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205102
UMLS CUI [2]
C0857093
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0020541
UMLS CUI [5,2]
C0205082
occurrence of stroke within 90 days before enrolment.
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
impairment of cognitive function or presence of any form of irreversible dementia.
Beschreibung

Impaired cognition | Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C0497327
recent history of psychiatric disease (including severe drug or alcohol abuse) that is likely to impair compliance with the study protocol.
Beschreibung

Mental disorders Impairing Protocol Compliance | Substance Use Disorders Impairing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0525058
platelet count <50 x103mm3 within 24 hours before enrolment.
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
creatinine clearance < 30ml/min.
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
high probability of non-compliance.
Beschreibung

Compliance behavior Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
the patient is deemed unsuitable by the clinical team for other reasons.
Beschreibung

Study Subject Participation Status Unsuitable for other reasons

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
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Ähnliche Modelle

Eligibility Heart Failure NCT01879670

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Ischemic cardiomyopathy | Cardiomyopathy, Dilated | Age
Item
patients with ischaemic or dilated cardiomyopathy aged 18 to 80 years.
boolean
C0349782 (UMLS CUI [1])
C0007193 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Symptoms Level | Therapy Optimal | Inpatient | Disease Management At home | Dependence Hospital care
Item
symptoms categorised by intermacs (interagency registry for mechanically assisted circulatory support) at level 3-6 despite optimal tolerated medical therapy. practically this includes patients who are in hospital or managing at home with substantial dependence on hospital care.
boolean
C1457887 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C0021562 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C4534363 (UMLS CUI [4,2])
C0439857 (UMLS CUI [5,1])
C0259945 (UMLS CUI [5,2])
Peak Oxygen consumption measurement | Respiratory Exchange Ratio Cardiopulmonary Exercise Test | 6-Minute Walk Test Distance | Exercise test Unable | Etiology Heart failure Severe
Item
peak vo2 <15ml/kg/min with respiratory exchange ratio>1 on cardiopulmonary exercise testing or a 6-minute walking distance <300m or inability to perform an exercise test due to the severity of heart failure.
boolean
C0444505 (UMLS CUI [1,1])
C1305742 (UMLS CUI [1,2])
C4049826 (UMLS CUI [2,1])
C2959886 (UMLS CUI [2,2])
C0430515 (UMLS CUI [3,1])
C0012751 (UMLS CUI [3,2])
C0015260 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
Informed Consent
Item
informed consent obtained prior to entering the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Etiology Heart failure | Thyroid Disease uncorrected | Hypertrophic Cardiomyopathy | Disorder of pericardium | Amyloidosis | Myocarditis
Item
cause of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or active myocarditis
boolean
C0015127 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C0007194 (UMLS CUI [3])
C0265122 (UMLS CUI [4])
C0002726 (UMLS CUI [5])
C0027059 (UMLS CUI [6])
Body Surface Area | Body mass index
Item
body surface area <1.2m2 or >2.3m2, or body mass index >32 kg/m2.
boolean
C0005902 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Severe chronic obstructive pulmonary disease | Percent predicted FEV1
Item
severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume in 1 second <50% of predicted.
boolean
C0730607 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
Pulmonary Hypertension | Pulmonary Vascular Resistance Wood units | Gradient Transpulmonary
Item
history of pulmonary hypertension with maintained pulmonary vascular resistance measured > 4 wood units or transpulmonary gradient >14mmhg.
boolean
C0020542 (UMLS CUI [1])
C0456261 (UMLS CUI [2,1])
C0439525 (UMLS CUI [2,2])
C0812409 (UMLS CUI [3,1])
C0442377 (UMLS CUI [3,2])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Liver disease intrinsic | Elevated liver enzymes level | Liver Dysfunction Severe | Liver Cirrhosis Severe | Portal Hypertension Severe
Item
evidence of intrinsic hepatic disease defined as liver enzyme levels > 5 times the upper limit of normal within 4 days before enrolment, severe liver dysfunction, cirrhosis or portal hypertension.
boolean
C0023895 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0857093 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0020541 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Cerebrovascular accident
Item
occurrence of stroke within 90 days before enrolment.
boolean
C0038454 (UMLS CUI [1])
Impaired cognition | Dementia
Item
impairment of cognitive function or presence of any form of irreversible dementia.
boolean
C0338656 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
Mental disorders Impairing Protocol Compliance | Substance Use Disorders Impairing Protocol Compliance
Item
recent history of psychiatric disease (including severe drug or alcohol abuse) that is likely to impair compliance with the study protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Platelet Count measurement
Item
platelet count <50 x103mm3 within 24 hours before enrolment.
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance < 30ml/min.
boolean
C0373595 (UMLS CUI [1])
Compliance behavior Unlikely
Item
high probability of non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Study Subject Participation Status Unsuitable for other reasons
Item
the patient is deemed unsuitable by the clinical team for other reasons.
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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