ID

39437

Beschreibung

Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01300650

Link

https://clinicaltrials.gov/show/NCT01300650

Stichworte

Versionen (1)
  1. 10.01.20 10.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01300650

Englisch

Eligibility Heart Failure NCT01300650

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of heart failure
Beschreibung

Heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
recent echocardiogram documenting left ventricular ejection fraction <40%
Beschreibung

Left ventricular ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
high sensitivity c-reactive protein >2 mg/l.
Beschreibung

Hypersensitivity C-reactive protein

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006560
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
recent changes (previous 3 months) in hf maintenance medications (beta-blockers, angiotensin converting enzyme [ace] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
Beschreibung

Change of medication Heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Aldosterone Antagonists | Vasodilator Agents | Cardiac Glycosides | Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0304516
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0002007
UMLS CUI [5]
C0042402
UMLS CUI [6]
C0007158
UMLS CUI [7]
C0012798
hospitalization for worsening hf or acute decompensated hf within the previous 12 months
Beschreibung

Hospitalization Heart failure Worsening | Hospitalization Decompensated cardiac failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332271
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0581377
anticipated need for cardiac resynchronization therapy (crt) or automated-implantable cardioverter defibrillator (aicd)
Beschreibung

Patient need for Cardiac Resynchronization Therapy | Patient need for Automatic Implantable Cardioverter-Defibrillators

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1167956
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0972395
angina or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ecg changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
Beschreibung

Angina Pectoris Limiting Exertion Maximum | ECG changes Limiting Exertion Maximum | Cardiopulmonary Exercise Test | Electrocardiographic changes | Ability Limited Detect Ischemia | Left Bundle-Branch Block

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015264
UMLS CUI [1,4]
C0806909
UMLS CUI [2,1]
C0855329
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0015264
UMLS CUI [2,4]
C0806909
UMLS CUI [3]
C2959886
UMLS CUI [4]
C0855329
UMLS CUI [5,1]
C0085732
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0442726
UMLS CUI [5,4]
C0022116
UMLS CUI [6]
C0023211
recent (<14 days) use of anti-inflammatory drugs (not including nsaids), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
Beschreibung

Anti-Inflammatory Agents | Exception NSAIDs | Chronic inflammatory disorder | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Malignant Neoplasms | Communicable Disease | Comorbidity Limiting Survival | Comorbidity Limiting Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003211
UMLS CUI [3]
C1290886
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0009450
UMLS CUI [8,1]
C0009488
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0038952
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C0439801
UMLS CUI [9,3]
C2732579
severe kidney dysfunction (egfr <30 ml/min)
Beschreibung

Abnormal renal function Severe | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151746
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
coagulopathy (inr >1.5), thrombocytopenia (<50,000/mm3), or leukopenia (absolute neutrophil count <1,500/mm3)
Beschreibung

Blood Coagulation Disorders | International Normalized Ratio | Thrombocytopenia | Leukopenia | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0023530
UMLS CUI [5]
C0948762
pregnancy (female patients will be required to take a urine pregnancy test)
Beschreibung

Pregnancy | Gender Urine pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430056
latex or rubber allergy
Beschreibung

Latex allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0577628
inability to give informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Ähnliche Modelle

Eligibility Heart Failure NCT01300650

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
confirmed diagnosis of heart failure
boolean
C0018801 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography
Item
recent echocardiogram documenting left ventricular ejection fraction <40%
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Hypersensitivity C-reactive protein
Item
high sensitivity c-reactive protein >2 mg/l.
boolean
C0020517 (UMLS CUI [1,1])
C0006560 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Change of medication Heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Aldosterone Antagonists | Vasodilator Agents | Cardiac Glycosides | Diuretics
Item
recent changes (previous 3 months) in hf maintenance medications (beta-blockers, angiotensin converting enzyme [ace] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
boolean
C0580105 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0304516 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0002007 (UMLS CUI [4])
C0042402 (UMLS CUI [5])
C0007158 (UMLS CUI [6])
C0012798 (UMLS CUI [7])
Hospitalization Heart failure Worsening | Hospitalization Decompensated cardiac failure
Item
hospitalization for worsening hf or acute decompensated hf within the previous 12 months
boolean
C0019993 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0581377 (UMLS CUI [2,2])
Patient need for Cardiac Resynchronization Therapy | Patient need for Automatic Implantable Cardioverter-Defibrillators
Item
anticipated need for cardiac resynchronization therapy (crt) or automated-implantable cardioverter defibrillator (aicd)
boolean
C0686904 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0972395 (UMLS CUI [2,2])
Angina Pectoris Limiting Exertion Maximum | ECG changes Limiting Exertion Maximum | Cardiopulmonary Exercise Test | Electrocardiographic changes | Ability Limited Detect Ischemia | Left Bundle-Branch Block
Item
angina or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ecg changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
boolean
C0002962 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015264 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0855329 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0015264 (UMLS CUI [2,3])
C0806909 (UMLS CUI [2,4])
C2959886 (UMLS CUI [3])
C0855329 (UMLS CUI [4])
C0085732 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0442726 (UMLS CUI [5,3])
C0022116 (UMLS CUI [5,4])
C0023211 (UMLS CUI [6])
Anti-Inflammatory Agents | Exception NSAIDs | Chronic inflammatory disorder | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Malignant Neoplasms | Communicable Disease | Comorbidity Limiting Survival | Comorbidity Limiting Completion of clinical trial
Item
recent (<14 days) use of anti-inflammatory drugs (not including nsaids), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
boolean
C0003209 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C1290886 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0009450 (UMLS CUI [7])
C0009488 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0038952 (UMLS CUI [8,3])
C0009488 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C2732579 (UMLS CUI [9,3])
Abnormal renal function Severe | Estimated Glomerular Filtration Rate
Item
severe kidney dysfunction (egfr <30 ml/min)
boolean
C0151746 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Blood Coagulation Disorders | International Normalized Ratio | Thrombocytopenia | Leukopenia | Absolute neutrophil count
Item
coagulopathy (inr >1.5), thrombocytopenia (<50,000/mm3), or leukopenia (absolute neutrophil count <1,500/mm3)
boolean
C0005779 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0023530 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
Pregnancy | Gender Urine pregnancy test
Item
pregnancy (female patients will be required to take a urine pregnancy test)
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
Latex allergy
Item
latex or rubber allergy
boolean
C0577628 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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