ID

29489

Beskrivning

Mechanisms of Action of Adaptive Servoventilation; ODM derived from: https://clinicaltrials.gov/show/NCT00976417

Länk

https://clinicaltrials.gov/show/NCT00976417

Nyckelord

Versioner (1)
  1. 2018-04-04 2018-04-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00976417

Engelsk

Eligibility Heart Failure NCT00976417

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
over 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
severe chronic heart failure (chf) with nyha class iii-iv or nyha class ii with at least one hospitalisation for hf within the last 12 months
Beskrivning

Chronic heart failure Severe New York Heart Association Classification | Chronic heart failure New York Heart Association Classification | Hospitalization Quantity Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0018801
left ventricular ejection fraction (lvef) <40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac mri documented less than 12 weeks before randomisation
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Radionuclide Angiography | Left ventricular ejection fraction Left ventriculography | Left ventricular ejection fraction MRI of Heart

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0034604
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0412219
UMLS CUI [4,1]
C0428772
UMLS CUI [4,2]
C0412692
diagnosis of sleep disordered breathing sdb (apnoea-hypopnoea-index (ahi >15/h) with
Beskrivning

Sleep Apnea Syndromes Apnea Hypopnea Index

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C4083070
≥ 50% central events and a central ahi ≥ 10/h)
Beskrivning

Event Main Percentage Apnea Hypopnea Index

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C4083070
clinically stable with no change in medication and no hospitalisation in preceding month
Beskrivning

Stable status Clinical | Pharmaceutical Preparations unchanged | Hospitalization Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0332197
optimised medical treatment according to the applicable guidelines
Beskrivning

Therapeutic procedure Optimization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698650
able to provide informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant chronic obstructive pulmonary disease (copd) with forced expiratory volume within one second (fev1) <50%
Beskrivning

Chronic Obstructive Airway Disease | FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0849974
oxygen saturation at rest during the day ≤ 90% at inclusion
Beskrivning

Oxygen saturation measurement At rest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C0443144
current use of positive airway pressure (pap) therapy
Beskrivning

Continuous Positive Airway Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0199451
life expectancy < 1 year for diseases unrelated to chronic heart failure
Beskrivning

Life Expectancy | Relationship Chronic heart failure Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0264716
UMLS CUI [2,3]
C0332197
cardiac surgery, percutaneous coronary intervention (pci), myocardial infarction (mi) or unstable angina within 6 months prior to randomisation
Beskrivning

Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
implantation of icd (implanted cardiodefibrillator) or crt (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
Beskrivning

Implantable defibrillator insertion Scheduled | Cardiac Resynchronization Therapy Scheduled | Implantable defibrillator insertion | Cardiac Resynchronization Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877213
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C1167956
UMLS CUI [2,2]
C0205539
UMLS CUI [3]
C0877213
UMLS CUI [4]
C1167956
transient ischemic attack (tia) or stroke within 3 months prior to randomisation
Beskrivning

Transient Ischemic Attack | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
Beskrivning

Heart valve disease (obstructive) (regurgitation) uncorrected | Valvular disease Resulting in Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1399139
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0543467
acute myocarditis/pericarditis within 6 months prior to randomisation
Beskrivning

Myocarditis | Pericarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0031046
untreated or therapy refractory restless legs syndrome (rls)
Beskrivning

Restless Legs Syndrome untreated | Restless Legs Syndrome refractory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0205269
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Heart Failure NCT00976417

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic heart failure Severe New York Heart Association Classification | Chronic heart failure New York Heart Association Classification | Hospitalization Quantity Heart failure
Item
severe chronic heart failure (chf) with nyha class iii-iv or nyha class ii with at least one hospitalisation for hf within the last 12 months
boolean
C0264716 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0018801 (UMLS CUI [3,3])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Radionuclide Angiography | Left ventricular ejection fraction Left ventriculography | Left ventricular ejection fraction MRI of Heart
Item
left ventricular ejection fraction (lvef) <40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac mri documented less than 12 weeks before randomisation
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0034604 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0412219 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4,1])
C0412692 (UMLS CUI [4,2])
Sleep Apnea Syndromes Apnea Hypopnea Index
Item
diagnosis of sleep disordered breathing sdb (apnoea-hypopnoea-index (ahi >15/h) with
boolean
C0037315 (UMLS CUI [1,1])
C4083070 (UMLS CUI [1,2])
Event Main Percentage Apnea Hypopnea Index
Item
≥ 50% central events and a central ahi ≥ 10/h)
boolean
C0441471 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C4083070 (UMLS CUI [1,4])
Stable status Clinical | Pharmaceutical Preparations unchanged | Hospitalization Absent
Item
clinically stable with no change in medication and no hospitalisation in preceding month
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure Optimization
Item
optimised medical treatment according to the applicable guidelines
boolean
C0087111 (UMLS CUI [1,1])
C2698650 (UMLS CUI [1,2])
Informed Consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease | FEV1
Item
significant chronic obstructive pulmonary disease (copd) with forced expiratory volume within one second (fev1) <50%
boolean
C0024117 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
Oxygen saturation measurement At rest
Item
oxygen saturation at rest during the day ≤ 90% at inclusion
boolean
C0523807 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Continuous Positive Airway Pressure
Item
current use of positive airway pressure (pap) therapy
boolean
C0199451 (UMLS CUI [1])
Life Expectancy | Relationship Chronic heart failure Absent
Item
life expectancy < 1 year for diseases unrelated to chronic heart failure
boolean
C0023671 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction | Angina, Unstable
Item
cardiac surgery, percutaneous coronary intervention (pci), myocardial infarction (mi) or unstable angina within 6 months prior to randomisation
boolean
C0018821 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
Implantable defibrillator insertion Scheduled | Cardiac Resynchronization Therapy Scheduled | Implantable defibrillator insertion | Cardiac Resynchronization Therapy
Item
implantation of icd (implanted cardiodefibrillator) or crt (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
boolean
C0877213 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C1167956 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0877213 (UMLS CUI [3])
C1167956 (UMLS CUI [4])
Transient Ischemic Attack | Cerebrovascular accident
Item
transient ischemic attack (tia) or stroke within 3 months prior to randomisation
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart valve disease (obstructive) (regurgitation) uncorrected | Valvular disease Resulting in Operative Surgical Procedures
Item
primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
boolean
C1399139 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C3258293 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Myocarditis | Pericarditis
Item
acute myocarditis/pericarditis within 6 months prior to randomisation
boolean
C0027059 (UMLS CUI [1])
C0031046 (UMLS CUI [2])
Restless Legs Syndrome untreated | Restless Legs Syndrome refractory
Item
untreated or therapy refractory restless legs syndrome (rls)
boolean
C0035258 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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