ID

40867

Descrição

Geriatric Out of Hospital Randomized Meal Trial in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02148679

Link

https://clinicaltrials.gov/show/NCT02148679

Palavras-chave

Versões (1)
  1. 28/05/2020 28/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02148679

Inglês

Eligibility Heart Failure NCT02148679

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
60 male and female patients aged ≥ 65 years with history of systemic hypertension and acutely decompensated heart failure (adhf; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). adhf will be confirmed by the study physician and defined as a combination of symptoms, signs, and hf-specific medical treatments. specifically, adhf will require that all four of the following conditions are met:
Descrição

Age | Hypertensive disease | ADHF Principal diagnosis | ADHF Secondary diagnosis | Symptoms Heart failure | Signs Heart failure | Therapy Specific Heart failure | Criteria All Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C1609524
UMLS CUI [3,2]
C0332137
UMLS CUI [4,1]
C1609524
UMLS CUI [4,2]
C0332138
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0018801
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C0018801
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0205369
UMLS CUI [7,3]
C0018801
UMLS CUI [8,1]
C0243161
UMLS CUI [8,2]
C0444868
UMLS CUI [8,3]
C1550543
≥1 symptom of hf (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
Descrição

Symptoms Quantity Heart failure | Dyspnea | Fatigue | Orthopnea | Paroxysmal nocturnal dyspnea | Worsening Symptoms Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0013404
UMLS CUI [3]
C0015672
UMLS CUI [4]
C0085619
UMLS CUI [5]
C1956415
UMLS CUI [6,1]
C0332271
UMLS CUI [6,2]
C1457887
UMLS CUI [6,3]
C0018801
≥ 2 signs of hf (pulmonary congestion on exam and/or chest x-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased b-type natriuretic peptide (bnp; ≥100 pg/ml)
Descrição

Signs Quantity Heart failure | Pulmonary congestion Examination | Pulmonary congestion Chest X-ray | Raised jugular venous pressure | Peripheral edema | Weight Gain Rapid | Brain natriuretic peptide increased

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0242073
UMLS CUI [2,2]
C0582103
UMLS CUI [3,1]
C0242073
UMLS CUI [3,2]
C0039985
UMLS CUI [4]
C0520861
UMLS CUI [5]
C0085649
UMLS CUI [6,1]
C0043094
UMLS CUI [6,2]
C0456962
UMLS CUI [7]
C1095988
change in medical treatment specifically targeting hf (diuretics, vasodilators, and/or neurohormonal modulating agents)
Descrição

Treatment changed | Targeted Therapy Heart failure | Diuretics | Vasodilator Agents | Neurohormone Modulation Agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2919691
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0018801
UMLS CUI [3]
C0012798
UMLS CUI [4]
C0042402
UMLS CUI [5,1]
C0597049
UMLS CUI [5,2]
C0443264
UMLS CUI [5,3]
C1254351
no other cause of the patient's symptoms and signs is apparent
Descrição

Symptoms Without Cause Other | Signs Without Cause Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0205394
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
systolic bp <100 mmhg at any time during hospitalization
Descrição

Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
use of inotropic therapy, severe valvular heart disease as the primary etiology of the patient's hf syndrome
Descrição

Inotropic agent | Heart valve disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304509
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C0205082
uncontrolled hypertension (systolic bp >180 mmhg or diastolic bp >100 mmhg) or systolic bp <110 on discharge
Descrição

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Systolic Pressure Hospital Discharge

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0586003
serum potassium >5.0 mmol/l during hospitalization or history of serum potassium >6.0 mmol/l
Descrição

Serum potassium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0302353
severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2 at discharge)
Descrição

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
severe anemia (hemoglobin < 9 gm/dl)
Descrição

Anemia, severe | Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518015
length of stay <48 hours or >14 days
Descrição

Length of Stay Hours | Length of Stay Days

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023303
UMLS CUI [1,2]
C0439227
UMLS CUI [2,1]
C0023303
UMLS CUI [2,2]
C0439228
co-morbidity with expected survival < 12 months
Descrição

Comorbidity | Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
active alcohol or substance abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
history of persistent noncompliance with treatment recommendations as judged by the investigators
Descrição

Treatment Compliance Lacking Persistent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0205322
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Eligibility Heart Failure NCT02148679

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease | ADHF Principal diagnosis | ADHF Secondary diagnosis | Symptoms Heart failure | Signs Heart failure | Therapy Specific Heart failure | Criteria All Fulfill
Item
60 male and female patients aged ≥ 65 years with history of systemic hypertension and acutely decompensated heart failure (adhf; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). adhf will be confirmed by the study physician and defined as a combination of symptoms, signs, and hf-specific medical treatments. specifically, adhf will require that all four of the following conditions are met:
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C1609524 (UMLS CUI [3,1])
C0332137 (UMLS CUI [3,2])
C1609524 (UMLS CUI [4,1])
C0332138 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C0311392 (UMLS CUI [6,1])
C0018801 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0205369 (UMLS CUI [7,2])
C0018801 (UMLS CUI [7,3])
C0243161 (UMLS CUI [8,1])
C0444868 (UMLS CUI [8,2])
C1550543 (UMLS CUI [8,3])
Symptoms Quantity Heart failure | Dyspnea | Fatigue | Orthopnea | Paroxysmal nocturnal dyspnea | Worsening Symptoms Heart failure
Item
≥1 symptom of hf (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
boolean
C1457887 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2])
C0015672 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C1956415 (UMLS CUI [5])
C0332271 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
C0018801 (UMLS CUI [6,3])
Signs Quantity Heart failure | Pulmonary congestion Examination | Pulmonary congestion Chest X-ray | Raised jugular venous pressure | Peripheral edema | Weight Gain Rapid | Brain natriuretic peptide increased
Item
≥ 2 signs of hf (pulmonary congestion on exam and/or chest x-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased b-type natriuretic peptide (bnp; ≥100 pg/ml)
boolean
C0311392 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0242073 (UMLS CUI [2,1])
C0582103 (UMLS CUI [2,2])
C0242073 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
C0520861 (UMLS CUI [4])
C0085649 (UMLS CUI [5])
C0043094 (UMLS CUI [6,1])
C0456962 (UMLS CUI [6,2])
C1095988 (UMLS CUI [7])
Treatment changed | Targeted Therapy Heart failure | Diuretics | Vasodilator Agents | Neurohormone Modulation Agent
Item
change in medical treatment specifically targeting hf (diuretics, vasodilators, and/or neurohormonal modulating agents)
boolean
C2919691 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3])
C0042402 (UMLS CUI [4])
C0597049 (UMLS CUI [5,1])
C0443264 (UMLS CUI [5,2])
C1254351 (UMLS CUI [5,3])
Symptoms Without Cause Other | Signs Without Cause Other
Item
no other cause of the patient's symptoms and signs is apparent
boolean
C1457887 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0311392 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
systolic bp <100 mmhg at any time during hospitalization
boolean
C0871470 (UMLS CUI [1])
Inotropic agent | Heart valve disease Severe
Item
use of inotropic therapy, severe valvular heart disease as the primary etiology of the patient's hf syndrome
boolean
C0304509 (UMLS CUI [1])
C0018824 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Systolic Pressure Hospital Discharge
Item
uncontrolled hypertension (systolic bp >180 mmhg or diastolic bp >100 mmhg) or systolic bp <110 on discharge
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0871470 (UMLS CUI [4,1])
C0586003 (UMLS CUI [4,2])
Serum potassium measurement
Item
serum potassium >5.0 mmol/l during hospitalization or history of serum potassium >6.0 mmol/l
boolean
C0302353 (UMLS CUI [1])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2 at discharge)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Anemia, severe | Hemoglobin measurement
Item
severe anemia (hemoglobin < 9 gm/dl)
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Length of Stay Hours | Length of Stay Days
Item
length of stay <48 hours or >14 days
boolean
C0023303 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0023303 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Comorbidity | Life Expectancy
Item
co-morbidity with expected survival < 12 months
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Substance Use Disorders
Item
active alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
Treatment Compliance Lacking Persistent
Item
history of persistent noncompliance with treatment recommendations as judged by the investigators
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
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