ID

39384

Description

The SMARTEX Heart Failure Study; ODM derived from: https://clinicaltrials.gov/show/NCT00917046

Link

https://clinicaltrials.gov/show/NCT00917046

Keywords

Versions (1)
  1. 1/5/20 1/5/20 -
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See clinicaltrials.gov

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January 5, 2020

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT00917046

English

Eligibility Heart Failure NCT00917046

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
congestive heart failure after myocardial infarction or dilated cardiomyopathy with:
Description

Congestive heart failure | Status post Myocardial Infarction | Status post Dilated Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0027051
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0007193
lvef < 0.35,
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
nyha class ii - iii,
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
stable without any signs of worsening for at least 6 weeks,
Description

Stable status | Worsening pattern Absent

Data type

boolean

Alias
UMLS CUI [1]
C0205360
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0332197
minimum 3 months of optimal medical treatment,
Description

Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
previous revascularisation or crt should be more than 6 months before inclusion.
Description

Revascularization Previous | Cardiac Resynchronization Therapy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0581603
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1167956
UMLS CUI [2,2]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant intercurrent illness last 6 weeks,
Description

Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
known severe ventricular arrhythmia with functional or prognostic significance unless protected with icd,
Description

Ventricular arrhythmia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205082
significant ischemia,
Description

Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0022116
hemodynamic deterioration or exercise-induced arrhythmia at baseline testing,
Description

Hemodynamics deterioration | Cardiac Arrhythmia Exercise induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0019010
UMLS CUI [1,2]
C0868945
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0239313
other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.,
Description

Heart Disease Limiting Exercise Tolerance | Valvular disease | Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0162521
UMLS CUI [2]
C3258293
UMLS CUI [3]
C0007194
co-morbidity that may significantly influence one-year prognosis,
Description

Comorbidity Influence Prognosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0033325
functional or mental disability that may limit exercise,
Description

Functional disability Limiting Exercise | Mental handicap Limiting Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C0872173
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0015259
patients scheduled for heart transplant at time of inclusion,
Description

Heart Transplantation Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0205539
a habit of regular vigorous exercise or participation in a program of exercise training less than 6 months before inclusion, or participation in another clinical trial,
Description

Vigorous physical activity | Exercise Training | Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C4267713
UMLS CUI [2]
C4279936
UMLS CUI [3]
C2348568
UMLS CUI [4]
C0008976
patients with copd with fev1 below 50% of expected values are excluded,
Description

Chronic Obstructive Airway Disease | Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0730561
patients taking oral corticosteroids are excluded in all cases.
Description

Adrenal Cortex Hormones Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
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Similar models

Eligibility Heart Failure NCT00917046

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure | Status post Myocardial Infarction | Status post Dilated Cardiomyopathy
Item
congestive heart failure after myocardial infarction or dilated cardiomyopathy with:
boolean
C0018802 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0027051 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0007193 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
lvef < 0.35,
boolean
C0428772 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class ii - iii,
boolean
C1275491 (UMLS CUI [1])
Stable status | Worsening pattern Absent
Item
stable without any signs of worsening for at least 6 weeks,
boolean
C0205360 (UMLS CUI [1])
C0332271 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Therapy Optimal
Item
minimum 3 months of optimal medical treatment,
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Revascularization Previous | Cardiac Resynchronization Therapy Previous
Item
previous revascularisation or crt should be more than 6 months before inclusion.
boolean
C0581603 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1167956 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Significant
Item
significant intercurrent illness last 6 weeks,
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Ventricular arrhythmia Severe
Item
known severe ventricular arrhythmia with functional or prognostic significance unless protected with icd,
boolean
C0085612 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Ischemia
Item
significant ischemia,
boolean
C0022116 (UMLS CUI [1])
Hemodynamics deterioration | Cardiac Arrhythmia Exercise induced
Item
hemodynamic deterioration or exercise-induced arrhythmia at baseline testing,
boolean
C0019010 (UMLS CUI [1,1])
C0868945 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0239313 (UMLS CUI [2,2])
Heart Disease Limiting Exercise Tolerance | Valvular disease | Hypertrophic Cardiomyopathy
Item
other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.,
boolean
C0018799 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0162521 (UMLS CUI [1,3])
C3258293 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
Comorbidity Influence Prognosis
Item
co-morbidity that may significantly influence one-year prognosis,
boolean
C0009488 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0033325 (UMLS CUI [1,3])
Functional disability Limiting Exercise | Mental handicap Limiting Exercise
Item
functional or mental disability that may limit exercise,
boolean
C0872173 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1306341 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
Heart Transplantation Scheduled
Item
patients scheduled for heart transplant at time of inclusion,
boolean
C0018823 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Vigorous physical activity | Exercise Training | Study Subject Participation Status | Clinical Trial
Item
a habit of regular vigorous exercise or participation in a program of exercise training less than 6 months before inclusion, or participation in another clinical trial,
boolean
C4267713 (UMLS CUI [1])
C4279936 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0008976 (UMLS CUI [4])
Chronic Obstructive Airway Disease | Percent predicted FEV1
Item
patients with copd with fev1 below 50% of expected values are excluded,
boolean
C0024117 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
Adrenal Cortex Hormones Oral
Item
patients taking oral corticosteroids are excluded in all cases.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
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