ID

39523

Description

The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF); ODM derived from: https://clinicaltrials.gov/show/NCT02354573

Link

https://clinicaltrials.gov/show/NCT02354573

Keywords

Versions (1)
  1. 1/23/20 1/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 23, 2020

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02354573

English

Eligibility Heart Failure NCT02354573

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant who is willing and able to give informed consent for participation in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 60 years and over (group 1, oxford).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients diagnosed with hfnef by esc criteria and have peak v02 ≤ 85% with a cardiac pattern of exercise limitation during cpex (group 1, oxford).
Description

Heart failure with normal ejection fraction | Oxygen consumption measurement Peak level | Pattern cardiac Exercise Limitation | Cardiopulmonary Exercise Test

Data type

boolean

Alias
UMLS CUI [1]
C2960127
UMLS CUI [2,1]
C1305742
UMLS CUI [2,2]
C0444505
UMLS CUI [3,1]
C0449774
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0015259
UMLS CUI [3,4]
C0449295
UMLS CUI [4]
C2959886
hypertensive controls aged 65 and over without hfnef and with peak v02 > 90% (group 2, aberdeen)
Description

Control Group Hypertensive | Age | Heart failure with normal ejection fraction Absent | Oxygen consumption measurement Peak level

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0857121
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C2960127
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1305742
UMLS CUI [4,2]
C0444505
able to perform exercise testing.
Description

Ability Exercise testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0015260
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the participant may not enter the study if any of the following apply:
Description

Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
lvef <50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
inability to tolerate mri scanning (claustrophobia, inability to lie flat)
Description

MRI scan Receive Unable | Claustrophobia | Lacking Able to lie down

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0560841
contraindications to cmr imaging (implantable devices or other metal implants, internal cardioverter-defibrillator, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium)
Description

Medical contraindication MRI of Heart | Implants | Metallic implant | Implantable defibrillator | Aneurysm clip Cranial | Eye foreign bodies Metallic | Hypersensitivity Gadolinium

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0412692
UMLS CUI [2]
C0021102
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0162589
UMLS CUI [5,1]
C0179977
UMLS CUI [5,2]
C3163632
UMLS CUI [6,1]
C0015401
UMLS CUI [6,2]
C2986473
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0016911
presence of other significant concomitant diseases such as ischaemic, valvular, pericardial heart disease or cardiomyopathy.
Description

Comorbidity Significant | Myocardial Ischemia | Heart valve disease | Disorder of pericardium | Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0018824
UMLS CUI [4]
C0265122
UMLS CUI [5]
C0878544
presence of asthma (contraindication to adenosine)
Description

Asthma | Medical contraindication Adenosine

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001443
presence of 2nd or 3rd degree av block (contraindications to ivabradine and adenosine)
Description

Second degree atrioventricular block | Complete atrioventricular block | Medical contraindication Ivabradine | Medical contraindication Adenosine

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0257190
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0001443
presence of sick sinus syndrome
Description

Sick Sinus Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0037052
presence of atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
significant bradycardia (hr <60 per minute).
Description

Bradycardia | Heart rate beats per minute

Data type

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0439385
objective evidence of lung disease on formal lung function testing
Description

Lung disease | Pulmonary function testing

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0024119
female participant who is pregnant, lactating or planning pregnancy during the course of the study
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
unable to perform exercise testing
Description

Exercise testing Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0015260
UMLS CUI [1,2]
C1299582
patient who is in terminally ill or is inappropriate for medication
Description

Terminal illness | Patient Inappropriate Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0013227
known hypersensitivity to ivabradine or adenosine
Description

Hypersensitivity Ivabradine | Adenosine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0257190
UMLS CUI [2]
C0571878
significantly impaired renal function (egfr<30ml/min)
Description

Renal Insufficiency | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
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Similar models

Eligibility Heart Failure NCT02354573

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
participant who is willing and able to give informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged 60 years and over (group 1, oxford).
boolean
C0001779 (UMLS CUI [1])
Heart failure with normal ejection fraction | Oxygen consumption measurement Peak level | Pattern cardiac Exercise Limitation | Cardiopulmonary Exercise Test
Item
patients diagnosed with hfnef by esc criteria and have peak v02 ≤ 85% with a cardiac pattern of exercise limitation during cpex (group 1, oxford).
boolean
C2960127 (UMLS CUI [1])
C1305742 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C0449774 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
C0449295 (UMLS CUI [3,4])
C2959886 (UMLS CUI [4])
Control Group Hypertensive | Age | Heart failure with normal ejection fraction Absent | Oxygen consumption measurement Peak level
Item
hypertensive controls aged 65 and over without hfnef and with peak v02 > 90% (group 2, aberdeen)
boolean
C0009932 (UMLS CUI [1,1])
C0857121 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C2960127 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1305742 (UMLS CUI [4,1])
C0444505 (UMLS CUI [4,2])
Ability Exercise testing
Item
able to perform exercise testing.
boolean
C0085732 (UMLS CUI [1,1])
C0015260 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
the participant may not enter the study if any of the following apply:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
lvef <50%
boolean
C0428772 (UMLS CUI [1])
MRI scan Receive Unable | Claustrophobia | Lacking Able to lie down
Item
inability to tolerate mri scanning (claustrophobia, inability to lie flat)
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
C0332268 (UMLS CUI [3,1])
C0560841 (UMLS CUI [3,2])
Medical contraindication MRI of Heart | Implants | Metallic implant | Implantable defibrillator | Aneurysm clip Cranial | Eye foreign bodies Metallic | Hypersensitivity Gadolinium
Item
contraindications to cmr imaging (implantable devices or other metal implants, internal cardioverter-defibrillator, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium)
boolean
C1301624 (UMLS CUI [1,1])
C0412692 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0162589 (UMLS CUI [4])
C0179977 (UMLS CUI [5,1])
C3163632 (UMLS CUI [5,2])
C0015401 (UMLS CUI [6,1])
C2986473 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0016911 (UMLS CUI [7,2])
Comorbidity Significant | Myocardial Ischemia | Heart valve disease | Disorder of pericardium | Cardiomyopathy
Item
presence of other significant concomitant diseases such as ischaemic, valvular, pericardial heart disease or cardiomyopathy.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2])
C0018824 (UMLS CUI [3])
C0265122 (UMLS CUI [4])
C0878544 (UMLS CUI [5])
Asthma | Medical contraindication Adenosine
Item
presence of asthma (contraindication to adenosine)
boolean
C0004096 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0001443 (UMLS CUI [2,2])
Second degree atrioventricular block | Complete atrioventricular block | Medical contraindication Ivabradine | Medical contraindication Adenosine
Item
presence of 2nd or 3rd degree av block (contraindications to ivabradine and adenosine)
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0257190 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0001443 (UMLS CUI [4,2])
Sick Sinus Syndrome
Item
presence of sick sinus syndrome
boolean
C0037052 (UMLS CUI [1])
Atrial Fibrillation
Item
presence of atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Bradycardia | Heart rate beats per minute
Item
significant bradycardia (hr <60 per minute).
boolean
C0428977 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0439385 (UMLS CUI [2,2])
Lung disease | Pulmonary function testing
Item
objective evidence of lung disease on formal lung function testing
boolean
C0024115 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female participant who is pregnant, lactating or planning pregnancy during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Exercise testing Unable
Item
unable to perform exercise testing
boolean
C0015260 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Terminal illness | Patient Inappropriate Pharmaceutical Preparations
Item
patient who is in terminally ill or is inappropriate for medication
boolean
C0679247 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Hypersensitivity Ivabradine | Adenosine allergy
Item
known hypersensitivity to ivabradine or adenosine
boolean
C0020517 (UMLS CUI [1,1])
C0257190 (UMLS CUI [1,2])
C0571878 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
significantly impaired renal function (egfr<30ml/min)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
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