ID

35926

Beschreibung

Exercise Training in Heart Failure: Changes in Cardiac Structure and Function; ODM derived from: https://clinicaltrials.gov/show/NCT02275819

Link

https://clinicaltrials.gov/show/NCT02275819

Stichworte

Versionen (1)
  1. 04.04.19 04.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. April 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02275819

Englisch

Eligibility Heart Failure NCT02275819

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha class ii or iii for the previous three months despite a minimum of 6 weeks of optimal treatment.
Beschreibung

New York Heart Association Classification | Therapy Optimal

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
age >50 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
lvef<45% (by echocardiogram or radionucleotide imaging study within 6 months of enrollment). if a patient has initiated or received any therapy that might improve the ejection fraction, the qualifying ef must be assessed after the patient is on a stable dose of these therapies. additionally the lvef of <45% will be confirmed with a brief echocardiogram prior to randomization. if lvef is not 45%, the patient will not be enrolled in to the study.
Beschreibung

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Radionuclide Imaging | Therapy Improvement Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0034606
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2986411
UMLS CUI [3,3]
C0232174
optimal therapy according to aha/acc and hfsa hf guidelines, including treatment with an ace inhibitor (or an angiotensin receptor blocker) and beta-blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
Beschreibung

Therapy Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Reason for Variation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0001645
UMLS CUI [5,1]
C0392360
UMLS CUI [5,2]
C0205419
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
major cardiovascular event or procedure within the prior 6 weeks.
Beschreibung

Cardiovascular event Major | Cardiovascular procedure Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0189573
UMLS CUI [2,2]
C0205164
dementia.
Beschreibung

Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
severe copd (fev1<50%), pvd, and/or anemia.
Beschreibung

Severe chronic obstructive pulmonary disease | FEV1 | Peripheral Vascular Diseases | Anemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0849974
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0002871
end-stage malignancy.
Beschreibung

Malignant Neoplasms End-stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205088
severe valvular heart disease.
Beschreibung

Heart valve disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
mechanical valve replacement requiring warfarin.
Beschreibung

Mechanical prosthetic valve Replacement | Requirement Warfarin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4062429
UMLS CUI [1,2]
C0035139
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0043031
orthopedic exercise limitation.
Beschreibung

Exercise Orthopedic Limitation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0029355
UMLS CUI [1,3]
C0449295
women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy Probably

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
psychiatric hospitalization within the last 3 months.
Beschreibung

Psychiatric hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0748061
icd device with heart rate limits that prohibit exercise assessments or exercise training. referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
Beschreibung

ICD Heart rate Limit | Exercise Assessment Excluded | Exercise Training Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C4279936
UMLS CUI [3,2]
C0332196
chronic etoh or drug dependency.
Beschreibung

Substance Dependence chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C0205191
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Ähnliche Modelle

Eligibility Heart Failure NCT02275819

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
New York Heart Association Classification | Therapy Optimal
Item
nyha class ii or iii for the previous three months despite a minimum of 6 weeks of optimal treatment.
boolean
C1275491 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Age
Item
age >50 years.
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Radionuclide Imaging | Therapy Improvement Cardiac ejection fraction
Item
lvef<45% (by echocardiogram or radionucleotide imaging study within 6 months of enrollment). if a patient has initiated or received any therapy that might improve the ejection fraction, the qualifying ef must be assessed after the patient is on a stable dose of these therapies. additionally the lvef of <45% will be confirmed with a brief echocardiogram prior to randomization. if lvef is not 45%, the patient will not be enrolled in to the study.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0034606 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C2986411 (UMLS CUI [3,2])
C0232174 (UMLS CUI [3,3])
Therapy Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Reason for Variation
Item
optimal therapy according to aha/acc and hfsa hf guidelines, including treatment with an ace inhibitor (or an angiotensin receptor blocker) and beta-blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C0392360 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Cardiovascular event Major | Cardiovascular procedure Major
Item
major cardiovascular event or procedure within the prior 6 weeks.
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0189573 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Dementia
Item
dementia.
boolean
C0497327 (UMLS CUI [1])
Severe chronic obstructive pulmonary disease | FEV1 | Peripheral Vascular Diseases | Anemia
Item
severe copd (fev1<50%), pvd, and/or anemia.
boolean
C0730607 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
Malignant Neoplasms End-stage
Item
end-stage malignancy.
boolean
C0006826 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
Heart valve disease Severe
Item
severe valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Mechanical prosthetic valve Replacement | Requirement Warfarin
Item
mechanical valve replacement requiring warfarin.
boolean
C4062429 (UMLS CUI [1,1])
C0035139 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0043031 (UMLS CUI [2,2])
Exercise Orthopedic Limitation
Item
orthopedic exercise limitation.
boolean
C0015259 (UMLS CUI [1,1])
C0029355 (UMLS CUI [1,2])
C0449295 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy Probably
Item
women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Psychiatric hospitalization
Item
psychiatric hospitalization within the last 3 months.
boolean
C0748061 (UMLS CUI [1])
ICD Heart rate Limit | Exercise Assessment Excluded | Exercise Training Excluded
Item
icd device with heart rate limits that prohibit exercise assessments or exercise training. referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
boolean
C0162589 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0015259 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C4279936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Substance Dependence chronic
Item
chronic etoh or drug dependency.
boolean
C0038580 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
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