ID

35907

Beschreibung

Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02200822

Link

https://clinicaltrials.gov/show/NCT02200822

Stichworte

Versionen (1)
  1. 03.04.19 03.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure (HF) NCT02200822

Englisch

Eligibility Heart Failure (HF) NCT02200822

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
crt implantation
Beschreibung

CRT Device Implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021107
based on class i recommendations of esc (european society of cardiology) guidelines:
Beschreibung

Recommendation Society Cardiology Europe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034866
UMLS CUI [1,2]
C0037455
UMLS CUI [1,3]
C0007189
UMLS CUI [1,4]
C0015176
left bundle branch block (lbbb) with qrs duration >150 ms and left ventricular ejection fraction (lvef) ≤35% who remained nyha functional class ii, iii and ambulatory iv despite adequate medical treatment
Beschreibung

Left Bundle-Branch Block | QRS complex duration | Left ventricular ejection fraction | New York Heart Association Classification | New York Heart Association Classification Ambulatory | Therapeutic procedure Adequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0429025
UMLS CUI [3]
C0428772
UMLS CUI [4]
C1275491
UMLS CUI [5,1]
C1275491
UMLS CUI [5,2]
C0439841
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0205411
lbbb with qrs duration 120-150 ms and lvef ≤ 35% who remain in nyha functional class ii, iii and ambulatory iv despite adequate medical treatment
Beschreibung

Left Bundle-Branch Block | QRS complex duration | Left ventricular ejection fraction | New York Heart Association Classification | New York Heart Association Classification Ambulatory | Therapeutic procedure Adequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0429025
UMLS CUI [3]
C0428772
UMLS CUI [4]
C1275491
UMLS CUI [5,1]
C1275491
UMLS CUI [5,2]
C0439841
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0205411
at the moment of inclusion: ≥ 6 months after implantation
Beschreibung

Timespan Post Implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0021107
at the moment of inclusion: normalised lvef (≥ 50%), lvidd/bsa (left ventricular internal diastolic diameter indexed to body surface area) ≤3.2 cm/m²(woman) en ≤3.1 cm/m² (men) or lvdv/bsa (left ventricular diastolic volume indexed to body surface area) ≤75 ml/m² (women) or ≤75 ml/m² (men)
Beschreibung

Left ventricular ejection fraction | Diastolic left ventricular internal diameter Relationship Body Surface Area | Left ventricle Diastolic Volume Relationship Body Surface Area | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0919652
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0005902
UMLS CUI [3,1]
C0225897
UMLS CUI [3,2]
C0449468
UMLS CUI [3,3]
C0012000
UMLS CUI [3,4]
C0439849
UMLS CUI [3,5]
C0005902
UMLS CUI [4]
C0079399
euvolemic clinical state and functioning in nyha class i
Beschreibung

Normovolemic | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0232092
UMLS CUI [2]
C1275491
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication for withdrawal of ace-i/arb such as diabetic nephropathy and proteinuria > 1g / 24 h
Beschreibung

Medical contraindication Withdrawal Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Withdrawal Angiotensin II receptor antagonist | Diabetic Nephropathy | Proteinuria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0003015
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2349954
UMLS CUI [2,3]
C0521942
UMLS CUI [3]
C0011881
UMLS CUI [4]
C0033687
severe ventricular arrythmia (sustained vt or ventricular fibrillation) occuring at the time lv function was normalized
Beschreibung

Ventricular arrhythmia Severe | Sustained ventricular tachycardia | Ventricular Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0750197
UMLS CUI [3]
C0042510
ischemic cardiomyopathy with evidence of scarring (scarring on mri or severe hypokinesia/akinesia in >1 lv wall segment on echocardiography)
Beschreibung

Ischemic cardiomyopathy | Cicatrization MRI | Hypokinesia Severe Wall segment Left ventricle Quantity | Akinesia Wall segment Left ventricle Quantity | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0349782
UMLS CUI [2,1]
C0008767
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C0086439
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0808411
UMLS CUI [3,4]
C0225897
UMLS CUI [3,5]
C1265611
UMLS CUI [4,1]
C0085623
UMLS CUI [4,2]
C0808411
UMLS CUI [4,3]
C0225897
UMLS CUI [4,4]
C1265611
UMLS CUI [5]
C0013516
known severe coronary atherosclerosis (stenosis ≥ 80%)
Beschreibung

Coronary Arteriosclerosis Severe | Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010054
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
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Ähnliche Modelle

Eligibility Heart Failure (HF) NCT02200822

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥18 years
boolean
C0001779 (UMLS CUI [1])
CRT Device Implantation
Item
crt implantation
boolean
C2936377 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Recommendation Society Cardiology Europe
Item
based on class i recommendations of esc (european society of cardiology) guidelines:
boolean
C0034866 (UMLS CUI [1,1])
C0037455 (UMLS CUI [1,2])
C0007189 (UMLS CUI [1,3])
C0015176 (UMLS CUI [1,4])
Left Bundle-Branch Block | QRS complex duration | Left ventricular ejection fraction | New York Heart Association Classification | New York Heart Association Classification Ambulatory | Therapeutic procedure Adequate
Item
left bundle branch block (lbbb) with qrs duration >150 ms and left ventricular ejection fraction (lvef) ≤35% who remained nyha functional class ii, iii and ambulatory iv despite adequate medical treatment
boolean
C0023211 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C1275491 (UMLS CUI [5,1])
C0439841 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0205411 (UMLS CUI [6,2])
Left Bundle-Branch Block | QRS complex duration | Left ventricular ejection fraction | New York Heart Association Classification | New York Heart Association Classification Ambulatory | Therapeutic procedure Adequate
Item
lbbb with qrs duration 120-150 ms and lvef ≤ 35% who remain in nyha functional class ii, iii and ambulatory iv despite adequate medical treatment
boolean
C0023211 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C1275491 (UMLS CUI [5,1])
C0439841 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0205411 (UMLS CUI [6,2])
Timespan Post Implantation
Item
at the moment of inclusion: ≥ 6 months after implantation
boolean
C0872291 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
Left ventricular ejection fraction | Diastolic left ventricular internal diameter Relationship Body Surface Area | Left ventricle Diastolic Volume Relationship Body Surface Area | Gender
Item
at the moment of inclusion: normalised lvef (≥ 50%), lvidd/bsa (left ventricular internal diastolic diameter indexed to body surface area) ≤3.2 cm/m²(woman) en ≤3.1 cm/m² (men) or lvdv/bsa (left ventricular diastolic volume indexed to body surface area) ≤75 ml/m² (women) or ≤75 ml/m² (men)
boolean
C0428772 (UMLS CUI [1])
C0919652 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0005902 (UMLS CUI [2,3])
C0225897 (UMLS CUI [3,1])
C0449468 (UMLS CUI [3,2])
C0012000 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C0005902 (UMLS CUI [3,5])
C0079399 (UMLS CUI [4])
Normovolemic | New York Heart Association Classification
Item
euvolemic clinical state and functioning in nyha class i
boolean
C0232092 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Withdrawal Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Withdrawal Angiotensin II receptor antagonist | Diabetic Nephropathy | Proteinuria
Item
contraindication for withdrawal of ace-i/arb such as diabetic nephropathy and proteinuria > 1g / 24 h
boolean
C1301624 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
C0011881 (UMLS CUI [3])
C0033687 (UMLS CUI [4])
Ventricular arrhythmia Severe | Sustained ventricular tachycardia | Ventricular Fibrillation
Item
severe ventricular arrythmia (sustained vt or ventricular fibrillation) occuring at the time lv function was normalized
boolean
C0085612 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0750197 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
Ischemic cardiomyopathy | Cicatrization MRI | Hypokinesia Severe Wall segment Left ventricle Quantity | Akinesia Wall segment Left ventricle Quantity | Echocardiography
Item
ischemic cardiomyopathy with evidence of scarring (scarring on mri or severe hypokinesia/akinesia in >1 lv wall segment on echocardiography)
boolean
C0349782 (UMLS CUI [1])
C0008767 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0086439 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0808411 (UMLS CUI [3,3])
C0225897 (UMLS CUI [3,4])
C1265611 (UMLS CUI [3,5])
C0085623 (UMLS CUI [4,1])
C0808411 (UMLS CUI [4,2])
C0225897 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
C0013516 (UMLS CUI [5])
Coronary Arteriosclerosis Severe | Stenosis Percentage
Item
known severe coronary atherosclerosis (stenosis ≥ 80%)
boolean
C0010054 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
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