ID

39506

Description

Contribution of Endothelin-1 to Exercise Intolerance in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02124824

Link

https://clinicaltrials.gov/show/NCT02124824

Keywords

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

See clinicaltrials.gov

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January 20, 2020

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02124824

English

Eligibility Heart Failure NCT02124824

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion/exclusion criteria:
Description

Eligibility Criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0205246
the study group will include subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, >3 months duration, ages 45-75 yrs) despite a minimum of 6 weeks of optimal treatment.
Description

Cardiomyopathy Stable Duration | Ischemic cardiomyopathy | Non-ischemic cardiomyopathy | Age | Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0878544
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0349782
UMLS CUI [3]
C0877438
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C2698651
optimal therapy will be according to aha/acc and hfsa hf guidelines, including treatment with ace and -blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
Description

Therapy Optimal | Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0003015
patient enrollment will be limited to those individuals with nyha class ii and iii symptoms, lvef<35%, with no or minimal smoking history (<15 pk yrs), and without pacemakers.
Description

Symptoms New York Heart Association Classification | Left ventricular ejection fraction | Tobacco use Absent | Tobacco use Minimal | Smoking cigarettes: ____ pack-years history | Artificial cardiac pacemaker Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C0543414
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0543414
UMLS CUI [4,2]
C0547040
UMLS CUI [5]
C2230126
UMLS CUI [6,1]
C0030163
UMLS CUI [6,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with atrial fibrillation or hf believed to be secondary to atrial fibrillation will be excluded.
Description

Atrial Fibrillation | Heart failure Secondary to Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0004238
patients with hf secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction) will also be excluded.
Description

Heart failure Secondary to Valvular disease | Exception Mitral Valve Insufficiency Secondary to Left Ventricular Dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C3258293
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026266
UMLS CUI [2,3]
C0175668
UMLS CUI [2,4]
C0242698
patients will be sedentary, defined here as no regular physical activity for at least the prior 6 months and current activity level will be documented by an activity questionnaire.
Description

Sedentary | Absence Physical activity Regular | Activity level Physical activity questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C1532253
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C0205272
UMLS CUI [3,1]
C0683317
UMLS CUI [3,2]
C4264334
patients must have no orthopedic limitations that would prohibit them from performing knee-extensor exercise.
Description

Orthopedic problem Preventing Knee Extensor Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C0029354
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0581537
UMLS CUI [1,4]
C0015259
due to the typical age of patients with hf, all women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years, and in women without a uterus, follicle stimulating hormone (fsh) >40 iu/l.
Description

Postmenopausal state | Female Sterilization | Amenorrhea Duration | Gender Uterus Absent | Follicle stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0042149
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0202022
women currently taking hormone replacement therapy (hrt) will be excluded from the proposed studies due to the direct vascular effects of hrt comorbidity exclusion criteria: patients with significant non-cardiac comorbidities, which if present could alter the study results, will be excluded.
Description

Gender Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0282402
these include a diagnosis of dementia
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
severe copd
Description

Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0730607
peripheral vascular disease
Description

Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
anemia
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
sleep-related breathing disorder
Description

Abnormal breathing Sleep Related

Data type

boolean

Alias
UMLS CUI [1,1]
C1260922
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0439849
severe valvular heart disease
Description

Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
diabetes (if on insulin therapy)
Description

Diabetes Mellitus | Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0557978
or end-stage malignancy
Description

End stage cancer

Data type

boolean

Alias
UMLS CUI [1]
C0741884
we will also exclude morbidly obese patients (bmi >35), patients with uncontrolled hypertension (>160/100), anemia (hgb<9) and severe renal insufficiency (individuals with creatinine clearance <30 by the cockcroft-gault formula).
Description

Obesity, Morbid | Body mass index | Uncontrolled hypertension | Anemia | Hemoglobin measurement | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0002871
UMLS CUI [5]
C0518015
UMLS CUI [6,1]
C1565489
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C2711451
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Similar models

Eligibility Heart Failure NCT02124824

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Eligibility Criteria General
Item
general inclusion/exclusion criteria:
boolean
C1516637 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Cardiomyopathy Stable Duration | Ischemic cardiomyopathy | Non-ischemic cardiomyopathy | Age | Therapy Optimal
Item
the study group will include subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, >3 months duration, ages 45-75 yrs) despite a minimum of 6 weeks of optimal treatment.
boolean
C0878544 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0349782 (UMLS CUI [2])
C0877438 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
Therapy Optimal | Angiotensin-Converting Enzyme Inhibitors
Item
optimal therapy will be according to aha/acc and hfsa hf guidelines, including treatment with ace and -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])
Symptoms New York Heart Association Classification | Left ventricular ejection fraction | Tobacco use Absent | Tobacco use Minimal | Smoking cigarettes: ____ pack-years history | Artificial cardiac pacemaker Absent
Item
patient enrollment will be limited to those individuals with nyha class ii and iii symptoms, lvef<35%, with no or minimal smoking history (<15 pk yrs), and without pacemakers.
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0543414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0543414 (UMLS CUI [4,1])
C0547040 (UMLS CUI [4,2])
C2230126 (UMLS CUI [5])
C0030163 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation | Heart failure Secondary to Atrial Fibrillation
Item
patients with atrial fibrillation or hf believed to be secondary to atrial fibrillation will be excluded.
boolean
C0004238 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Heart failure Secondary to Valvular disease | Exception Mitral Valve Insufficiency Secondary to Left Ventricular Dysfunction
Item
patients with hf secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction) will also be excluded.
boolean
C0018801 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C3258293 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0026266 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C0242698 (UMLS CUI [2,4])
Sedentary | Absence Physical activity Regular | Activity level Physical activity questionnaire
Item
patients will be sedentary, defined here as no regular physical activity for at least the prior 6 months and current activity level will be documented by an activity questionnaire.
boolean
C1532253 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0683317 (UMLS CUI [3,1])
C4264334 (UMLS CUI [3,2])
Orthopedic problem Preventing Knee Extensor Exercise
Item
patients must have no orthopedic limitations that would prohibit them from performing knee-extensor exercise.
boolean
C0029354 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0581537 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
Postmenopausal state | Female Sterilization | Amenorrhea Duration | Gender Uterus Absent | Follicle stimulating hormone measurement
Item
due to the typical age of patients with hf, all women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years, and in women without a uterus, follicle stimulating hormone (fsh) >40 iu/l.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0042149 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0202022 (UMLS CUI [5])
Gender Hormone replacement therapy
Item
women currently taking hormone replacement therapy (hrt) will be excluded from the proposed studies due to the direct vascular effects of hrt comorbidity exclusion criteria: patients with significant non-cardiac comorbidities, which if present could alter the study results, will be excluded.
boolean
C0079399 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
Dementia
Item
these include a diagnosis of dementia
boolean
C0497327 (UMLS CUI [1])
Severe chronic obstructive pulmonary disease
Item
severe copd
boolean
C0730607 (UMLS CUI [1])
Peripheral Vascular Disease
Item
peripheral vascular disease
boolean
C0085096 (UMLS CUI [1])
Anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
Abnormal breathing Sleep Related
Item
sleep-related breathing disorder
boolean
C1260922 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Diabetes Mellitus | Insulin regime
Item
diabetes (if on insulin therapy)
boolean
C0011849 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
End stage cancer
Item
or end-stage malignancy
boolean
C0741884 (UMLS CUI [1])
Obesity, Morbid | Body mass index | Uncontrolled hypertension | Anemia | Hemoglobin measurement | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
we will also exclude morbidly obese patients (bmi >35), patients with uncontrolled hypertension (>160/100), anemia (hgb<9) and severe renal insufficiency (individuals with creatinine clearance <30 by the cockcroft-gault formula).
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C1565489 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2711451 (UMLS CUI [7])
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