ID

44414

Beskrivning

DECIDE-HF: Heart Rate Variability in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00949676

Länk

https://clinicaltrials.gov/show/NCT00949676

Nyckelord

Versioner (2)
  1. 2018-11-05 2018-11-05 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Systolic Heart Failure NCT00949676

Engelsk

Eligibility Systolic Heart Failure NCT00949676

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has signed and dated the study-specific informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
subject is 18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
subject is expected to remain available for follow-ups
Beskrivning

Study Subject Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
subject is able and willing to comply with the protocol requirements
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
subject has predominant normal sinus rhythm
Beskrivning

Normal sinus rhythm Predominant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232202
UMLS CUI [1,2]
C1542147
subject has systolic heart failure and is at the moment of enrollment in nyha class ii or iii and has an ejection fraction of less then 40%
Beskrivning

Systolic Heart Failure New York Heart Association Classification | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135191
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0232174
subject has had a hf-related hospitalization in the past 12 months
Beskrivning

Hospitalization Due to Heart Failure

Datatyp

boolean

Alias
UMLS CUI [1]
C3898876
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject needs permanent atrial pacing (> 10%)
Beskrivning

Patient need for Intra-atrial pacing Permanent Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0199647
UMLS CUI [1,3]
C0205355
UMLS CUI [1,4]
C0439165
subject has intermittent 2nd or intermittent 3rd degree block
Beskrivning

Intermittent second degree atrioventricular block | Complete atrioventricular block Intermittent

Datatyp

boolean

Alias
UMLS CUI [1]
C0344418
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0205267
subject has persistent or permanent af
Beskrivning

Persistent atrial fibrillation | Permanent atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
subject has long qt syndrome, brugada syndrome, jervell and lange- nielsen syndrome, romano-ward syndrome, andersen-tawil syndrome or timothy's syndrome
Beskrivning

Long QT Syndrome | Brugada Syndrome | Jervell-Lange Nielsen Syndrome | Romano-Ward Syndrome | Andersen Tawil Syndrome | Timothy syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C1142166
UMLS CUI [3]
C0022387
UMLS CUI [4]
C4551647
UMLS CUI [5]
C1563715
UMLS CUI [6]
C1832916
subject has had recent (<2 months) acute coronary syndrome
Beskrivning

Acute Coronary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
subject has had recent (<2 months) revascularization
Beskrivning

Revascularization

Datatyp

boolean

Alias
UMLS CUI [1]
C0581603
subject has a pending cardiac transplant or revascularization
Beskrivning

Heart Transplantation pending | Cardiac Revascularization pending

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1611271
UMLS CUI [2,1]
C0027056
UMLS CUI [2,2]
C1611271
subject has severe stenotic valvular heart disease
Beskrivning

Heart valve stenosis Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0264878
UMLS CUI [1,2]
C0205082
subject has severe pulmonary (forced expiratory volume in 1 s < 1 l) hepatic or renal (plasma creatinine > 0.2 mmol/l) disease
Beskrivning

Lung disease Severe | FEV1 | Liver disease Severe | Kidney Disease Severe | Plasma creatinine measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0849974
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C1278055
subject is participating in another study that may affect the results of this study
Beskrivning

Study Subject Participation Status Affecting Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
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Similar models

Eligibility Systolic Heart Failure NCT00949676

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject has signed and dated the study-specific informed consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
subject is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Study Subject Available Follow-up
Item
subject is expected to remain available for follow-ups
boolean
C0681850 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Protocol Compliance
Item
subject is able and willing to comply with the protocol requirements
boolean
C0525058 (UMLS CUI [1])
Normal sinus rhythm Predominant
Item
subject has predominant normal sinus rhythm
boolean
C0232202 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Systolic Heart Failure New York Heart Association Classification | Cardiac ejection fraction
Item
subject has systolic heart failure and is at the moment of enrollment in nyha class ii or iii and has an ejection fraction of less then 40%
boolean
C1135191 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
Hospitalization Due to Heart Failure
Item
subject has had a hf-related hospitalization in the past 12 months
boolean
C3898876 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient need for Intra-atrial pacing Permanent Percentage
Item
subject needs permanent atrial pacing (> 10%)
boolean
C0686904 (UMLS CUI [1,1])
C0199647 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Intermittent second degree atrioventricular block | Complete atrioventricular block Intermittent
Item
subject has intermittent 2nd or intermittent 3rd degree block
boolean
C0344418 (UMLS CUI [1])
C0151517 (UMLS CUI [2,1])
C0205267 (UMLS CUI [2,2])
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
subject has persistent or permanent af
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Long QT Syndrome | Brugada Syndrome | Jervell-Lange Nielsen Syndrome | Romano-Ward Syndrome | Andersen Tawil Syndrome | Timothy syndrome
Item
subject has long qt syndrome, brugada syndrome, jervell and lange- nielsen syndrome, romano-ward syndrome, andersen-tawil syndrome or timothy's syndrome
boolean
C0023976 (UMLS CUI [1])
C1142166 (UMLS CUI [2])
C0022387 (UMLS CUI [3])
C4551647 (UMLS CUI [4])
C1563715 (UMLS CUI [5])
C1832916 (UMLS CUI [6])
Acute Coronary Syndrome
Item
subject has had recent (<2 months) acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Revascularization
Item
subject has had recent (<2 months) revascularization
boolean
C0581603 (UMLS CUI [1])
Heart Transplantation pending | Cardiac Revascularization pending
Item
subject has a pending cardiac transplant or revascularization
boolean
C0018823 (UMLS CUI [1,1])
C1611271 (UMLS CUI [1,2])
C0027056 (UMLS CUI [2,1])
C1611271 (UMLS CUI [2,2])
Heart valve stenosis Severe
Item
subject has severe stenotic valvular heart disease
boolean
C0264878 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Lung disease Severe | FEV1 | Liver disease Severe | Kidney Disease Severe | Plasma creatinine measurement
Item
subject has severe pulmonary (forced expiratory volume in 1 s < 1 l) hepatic or renal (plasma creatinine > 0.2 mmol/l) disease
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0849974 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1278055 (UMLS CUI [5])
Study Subject Participation Status Affecting Research results
Item
subject is participating in another study that may affect the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
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