ID

40447

Descrição

Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01690091

Link

https://clinicaltrials.gov/show/NCT01690091

Palavras-chave

Versões (2)
  1. 21/04/2020 21/04/2020 -
  2. 21/04/2020 21/04/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de abril de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Insulin Resistance NCT01690091

Inglês

Eligibility Insulin Resistance NCT01690091

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chronic heart failure will be defined by the following criteria (all must be included):
Descrição

Chronic heart failure | Inclusion criteria All Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C1550543
diagnosis of hf known for at least 6 months
Descrição

Heart failure Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0449238
medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - x-ray findings or swelling of lower extremities
Descrição

Medical History Hospitalization Heart Decompensation | Patient need for Parenteral therapy Congestion | X-ray of both lower extremities | Edema of lower extremity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C1961112
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0259961
UMLS CUI [2,3]
C0700148
UMLS CUI [3]
C3861120
UMLS CUI [4]
C0239340
stable drug therapy at least 1 month
Descrição

Pharmacotherapy Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
treatment with diuretics (thiazide or furosemide)
Descrição

Diuretics | Thiazide | Furosemide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2]
C0012802
UMLS CUI [3]
C0016860
lvef below 50%
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
2. the presence of diabetes will be defined by:
Descrição

Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
diagnosis and treatment of type 2 diabetes in the medical history
Descrição

Medical History Non-Insulin-Dependent Diabetes Mellitus | Therapy Non-Insulin-Dependent Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011860
screening blood sample:
Descrição

Blood specimen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178913
the value of hba1c(according to ifcc)≥ 4.8% + fasting glucose ≥ 7.0 mmol /
Descrição

Hemoglobin A1c measurement | Fasting glucose measurement Venous plasma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0202045
UMLS CUI [2,2]
C3838734
l in venous plasma or
Descrição

ID.11

Tipo de dados

boolean

the value of hba1c ≥ 4.8%(according to ifcc) + random blood glucose ≥ 11.1 mmol/l in venous plasma
Descrição

Hemoglobin A1c measurement | Random blood glucose measurement Venous plasma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0428567
UMLS CUI [2,2]
C3838734
or ogtt - blood glucose level at 120 min ≥ 11.1 mmol/l ogtt is indicated just in case of positivity of one of the criteria (fasting glucose + hba1c or hba1c + random blood glucose)
Descrição

Oral Glucose Tolerance Test | Blood glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029161
UMLS CUI [2]
C0392201
treatment of diabetes - by diet only
Descrição

Diet therapy Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0011849
women and men aged 40-70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (kg/m2) in the range of 20-35
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
the range of hba1c between 4-6,5% ifcc
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
signed informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the planned cardiac intervention during the study that affect the function of the heart (revascularization including pci, heart surgery, implantation of pacemaker, rf ablation; urgent candidate for ots
Descrição

Intervention cardiac Affecting Cardiac function | Revascularization | Percutaneous Coronary Intervention | Cardiac Surgery procedures | Implantation of cardiac pacemaker | Radiofrequency ablation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0232164
UMLS CUI [2]
C0581603
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0018821
UMLS CUI [5]
C0189842
UMLS CUI [6]
C0850292
2. metabolic disease, including: 1 type diabetes, decompensated thyreopathy (note: patients with hypothyroidism and stable substitution (the last 3 months) of normal tsh levels may participate in the study
Descrição

Metabolic Disease | Diabetes Mellitus, Insulin-Dependent | Thyroid Disease Decompensated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0011854
UMLS CUI [3,1]
C0040128
UMLS CUI [3,2]
C0205434
3. treatment with insulin or pad one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
Descrição

Insulin regime Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0332185
4. pregnancy (positive β-hcg test), breast feeding, trying to become pregnant
Descrição

Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0420843
5. clinically significant anemia with hemoglobin below 100 g/l
Descrição

Anemia | Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
6. renal insufficiency with egf below 0.7 ml/s
Descrição

Renal Insufficiency | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
7. atrial fibrillation - present during screening test
Descrição

Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004238
8. the presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
Descrição

Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Electrocardiography | Lung disease | Nervous system disorder | Inflammatory disorder

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0022885
UMLS CUI [4]
C1623258
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0027765
UMLS CUI [7]
C1290884
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Similar models

Eligibility Insulin Resistance NCT01690091

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic heart failure | Inclusion criteria All Fulfill
Item
1. chronic heart failure will be defined by the following criteria (all must be included):
boolean
C0264716 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Heart failure Duration
Item
diagnosis of hf known for at least 6 months
boolean
C0018801 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Medical History Hospitalization Heart Decompensation | Patient need for Parenteral therapy Congestion | X-ray of both lower extremities | Edema of lower extremity
Item
medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - x-ray findings or swelling of lower extremities
boolean
C0262926 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1961112 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0259961 (UMLS CUI [2,2])
C0700148 (UMLS CUI [2,3])
C3861120 (UMLS CUI [3])
C0239340 (UMLS CUI [4])
Pharmacotherapy Stable
Item
stable drug therapy at least 1 month
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Diuretics | Thiazide | Furosemide
Item
treatment with diuretics (thiazide or furosemide)
boolean
C0012798 (UMLS CUI [1])
C0012802 (UMLS CUI [2])
C0016860 (UMLS CUI [3])
Left ventricular ejection fraction
Item
lvef below 50%
boolean
C0428772 (UMLS CUI [1])
Diabetes Mellitus
Item
2. the presence of diabetes will be defined by:
boolean
C0011849 (UMLS CUI [1])
Medical History Non-Insulin-Dependent Diabetes Mellitus | Therapy Non-Insulin-Dependent Diabetes Mellitus
Item
diagnosis and treatment of type 2 diabetes in the medical history
boolean
C0262926 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Blood specimen
Item
screening blood sample:
boolean
C0178913 (UMLS CUI [1])
Hemoglobin A1c measurement | Fasting glucose measurement Venous plasma
Item
the value of hba1c(according to ifcc)≥ 4.8% + fasting glucose ≥ 7.0 mmol /
boolean
C0474680 (UMLS CUI [1])
C0202045 (UMLS CUI [2,1])
C3838734 (UMLS CUI [2,2])
ID.11
Item
l in venous plasma or
boolean
Hemoglobin A1c measurement | Random blood glucose measurement Venous plasma
Item
the value of hba1c ≥ 4.8%(according to ifcc) + random blood glucose ≥ 11.1 mmol/l in venous plasma
boolean
C0474680 (UMLS CUI [1])
C0428567 (UMLS CUI [2,1])
C3838734 (UMLS CUI [2,2])
Oral Glucose Tolerance Test | Blood glucose measurement
Item
or ogtt - blood glucose level at 120 min ≥ 11.1 mmol/l ogtt is indicated just in case of positivity of one of the criteria (fasting glucose + hba1c or hba1c + random blood glucose)
boolean
C0029161 (UMLS CUI [1])
C0392201 (UMLS CUI [2])
Diet therapy Diabetes Mellitus
Item
treatment of diabetes - by diet only
boolean
C0012159 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Age
Item
women and men aged 40-70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (kg/m2) in the range of 20-35
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
the range of hba1c between 4-6,5% ifcc
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Intervention cardiac Affecting Cardiac function | Revascularization | Percutaneous Coronary Intervention | Cardiac Surgery procedures | Implantation of cardiac pacemaker | Radiofrequency ablation
Item
1. the planned cardiac intervention during the study that affect the function of the heart (revascularization including pci, heart surgery, implantation of pacemaker, rf ablation; urgent candidate for ots
boolean
C0184661 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0232164 (UMLS CUI [1,4])
C0581603 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C0189842 (UMLS CUI [5])
C0850292 (UMLS CUI [6])
Metabolic Disease | Diabetes Mellitus, Insulin-Dependent | Thyroid Disease Decompensated
Item
2. metabolic disease, including: 1 type diabetes, decompensated thyreopathy (note: patients with hypothyroidism and stable substitution (the last 3 months) of normal tsh levels may participate in the study
boolean
C0025517 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0040128 (UMLS CUI [3,1])
C0205434 (UMLS CUI [3,2])
Insulin regime Recent
Item
3. treatment with insulin or pad one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
boolean
C0557978 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive
Item
4. pregnancy (positive β-hcg test), breast feeding, trying to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0420843 (UMLS CUI [4])
Anemia | Hemoglobin measurement
Item
5. clinically significant anemia with hemoglobin below 100 g/l
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
6. renal insufficiency with egf below 0.7 ml/s
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Atrial Fibrillation
Item
7. atrial fibrillation - present during screening test
boolean
C0004238 (UMLS CUI [1])
Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Electrocardiography | Lung disease | Nervous system disorder | Inflammatory disorder
Item
8. the presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C1290884 (UMLS CUI [7])
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