ID

44414

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00949676

Stichworte

Versionen (2)
  1. 05.11.18 05.11.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY-NC 3.0
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Eligibility Systolic Heart Failure NCT00949676

Englisch

Eligibility Systolic Heart Failure NCT00949676

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

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

Study Subject Available Follow-up

Datentyp

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
Beschreibung

Protocol Compliance

Datentyp

boolean

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

Normal sinus rhythm Predominant

Datentyp

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%
Beschreibung

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

Datentyp

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
Beschreibung

Hospitalization Due to Heart Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C3898876
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Patient need for Intra-atrial pacing Permanent Percentage

Datentyp

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
Beschreibung

Intermittent second degree atrioventricular block | Complete atrioventricular block Intermittent

Datentyp

boolean

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

Persistent atrial fibrillation | Permanent atrial fibrillation

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Acute Coronary Syndrome

Datentyp

boolean

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

Revascularization

Datentyp

boolean

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

Heart Transplantation pending | Cardiac Revascularization pending

Datentyp

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
Beschreibung

Heart valve stenosis Severe

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status Affecting Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
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Ähnliche Modelle

Eligibility Systolic Heart Failure NCT00949676

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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