Informações:
Falhas:
ID
12603
Descrição
Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT); ODM derived from: https://clinicaltrials.gov/show/NCT01800968
Link
https://clinicaltrials.gov/show/NCT01800968
Palavras-chave
Versões (1)
- 04/12/2015 04/12/2015 -
Transferido a
4 de dezembro de 2015
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Acute Heart Failure NCT01800968
Eligibility Acute Heart Failure NCT01800968
- StudyEvent: Eligibility
Similar models
Eligibility Acute Heart Failure NCT01800968
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
age 18 years
boolean
C0001779 (UMLS CUI [1])
acute heart failure
Item
ahfs as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
boolean
C0264714 (UMLS CUI [1])
ahfs is the primary cause of hospitalization
Item
ahfs is the primary cause of hospitalization
boolean
C0264714 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0019993 (UMLS CUI [2])
prior clinical diagnosis of hf
Item
prior clinical diagnosis of hf
boolean
C0018801 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C0011900 (UMLS CUI [2])
left ventricular ejection fraction
Item
left ventricular ejection fraction(lvef) ≤ 40 percent during the preceding 3 months (if no echo within the preceding 3 months, an lvef ≤ 30 percent during the preceding three years is acceptable)
boolean
C0428772 (UMLS CUI [1])
evidence-based medication
Item
on evidence-based medication for hf (including beta-blocker and ace-inhibitor/arb) or previously deemed intolerant
boolean
C1740791 (UMLS CUI [1])
loop diuretic or loop diuretic combined with a thiazide
Item
use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for ahfs (a lower dose of a loop diuretic combined with a thiazide will count as an "equivalent")
boolean
C0354100 (UMLS CUI [1])
C3654030 (UMLS CUI [2])
C3654030 (UMLS CUI [2])
informed consent
Item
willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
ahfs due to acute myocarditis or acute myocardial infarction
Item
ahfs due to acute myocarditis or acute myocardial infarction
boolean
C0155686 (UMLS CUI [1])
C0155626 (UMLS CUI [2])
C0155626 (UMLS CUI [2])
significant arrhythmias
Item
2. ongoing hemodynamically significant arrhythmias contributing to hf decompensation
boolean
C0003811 (UMLS CUI [1])
mechanical circulatory support
Item
inotrope, intra-aortic balloon pump (iabp) or other mechanical circulatory support use at the time of consent. prior use will not exclude a patient.
boolean
C3274791 (UMLS CUI [1])
left ventricular assist device
Item
4. current or planned left ventricular assist device therapy in next 180 days
boolean
C0181598 (UMLS CUI [1])
Transplantation eligible
Item
united network for organ sharing status 1a or 1b
boolean
C0040732 (UMLS CUI [1])
b-type natriuretic peptide(bnp)< 250 or nt-probnp<1,000 (not required per protocol but if available and too low would be an exclusion; within 48 hours of consent
Item
b-type natriuretic peptide(bnp)< 250 or nt-probnp<1,000 (not required per protocol but if available and too low would be an exclusion; within 48 hours of consent)
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
C3272900 (UMLS CUI [2])
hemoglobin (hgb) < 8.0 g/dl
Item
hemoglobin (hgb) < 8.0 g/dl
boolean
C0002871 (UMLS CUI [1])
glomerular filtration rate
Item
8. glomerular filtration rate(gfr) < 20 ml/min/1.73 m2 within 48 hours of consent
boolean
C0017654 (UMLS CUI [1])
systolic blood pressure < 80 mmhg at consent
Item
systolic blood pressure < 80 mmhg at consent
boolean
C0020649 (UMLS CUI [1])
Tachycardia
Item
resting heart rate > 110 at consent
boolean
C0039231 (UMLS CUI [1])
acute coronary syndrome
Item
acute coronary syndrome within 4 weeks as defined by electrocardiographic (ecg) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
boolean
C0948089 (UMLS CUI [1])
percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
Item
percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1322649 (UMLS CUI [3])
C0010055 (UMLS CUI [2])
C1322649 (UMLS CUI [3])
primary hypertrophic cardiomyopathy
Item
primary hypertrophic cardiomyopathy
boolean
C0264847 (UMLS CUI [1])
infiltrative cardiomyopathy
Item
infiltrative cardiomyopathy
boolean
C0878544 (UMLS CUI [1])
constrictive pericarditis
Item
constrictive pericarditis or tamponade
boolean
C0031048 (UMLS CUI [1])
complex congenital heart disease
Item
complex congenital heart disease
boolean
C0152021 (UMLS CUI [1])
non-cardiac pulmonary edema
Item
non-cardiac pulmonary edema
boolean
C0034063 (UMLS CUI [1])
more than moderate aortic or mitral stenosis
Item
more than moderate aortic or mitral stenosis
boolean
C0155572 (UMLS CUI [1])
valve disease
Item
intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
boolean
C0018824 (UMLS CUI [1])
sepsis, active infection (excluding cystitis) or other comorbidity driving the hf decompensation
Item
sepsis, active infection (excluding cystitis) or other comorbidity driving the hf decompensation
boolean
C0009488 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0015127 (UMLS CUI [3])
C0018801 (UMLS CUI [2])
C0015127 (UMLS CUI [3])
severe liver disease
Item
acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, international normalized ration (inr) > 1.7 in the absence of anticoagulation treatment
boolean
C3829821 (UMLS CUI [1])
life expectancy
Item
terminal illness (other than hf) with expected survival of less than 1 year
boolean
C0023671 (UMLS CUI [1])
adverse reaction
Item
previous adverse reaction to the study drug
boolean
C0559546 (UMLS CUI [1])
receipt of any investigational product in the previous 30 days
Item
receipt of any investigational product in the previous 30 days.
boolean
C2348568 (UMLS CUI [1])
enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months
Item
enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.
boolean
C2348568 (UMLS CUI [1])
inability to comply with planned study procedures
Item
inability to comply with planned study procedures
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
pregnancy or breastfeeding
Item
pregnancy or breastfeeding mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
childbearing potential
Item
women of reproductive age not on adequate contraception
boolean
C1960468 (UMLS CUI [1])
pancreatitis
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
gastroparesis
Item
history of symptomatic gastroparesis
boolean
C0152020 (UMLS CUI [1])
familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (men2)
Item
familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (men2)
boolean
C0238462 (UMLS CUI [1])
C0025268 (UMLS CUI [2])
C0025268 (UMLS CUI [2])
weight-loss surgery
Item
prior weight-loss surgery (i.e., roux-en-y gastric bypass) or other gastric surgery associated with increased endogenous glp-1 production
boolean
C1456587 (UMLS CUI [1])
glp-1 receptor agonists
Item
prior or ongoing treatment with glp-1 receptor agonists
boolean
C2917359 (UMLS CUI [1])
dipeptidyl peptide-iv inhibitor
Item
ongoing treatment with dipeptidyl peptide-iv inhibitors (1 week washout required)
boolean
C0081937 (UMLS CUI [1])
thiazolidinedione
Item
ongoing treatment with thiazolidinedione
boolean
C1257987 (UMLS CUI [1])
copd oxygen dependent
Item
oxygen-dependent chronic obstructive pulmonary disease
boolean
C1737722 (UMLS CUI [1])
diabetic patients with history of 2 or more severe hypoglycemia, diabetic ketoacidosis(dka) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
Item
diabetic patients with history of 2 or more severe hypoglycemia, diabetic ketoacidosis(dka) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
boolean
C0011880 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
C0020615 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
type 1 diabetes mellitus
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
inadequate glycemic control
Item
if diabetic, inadequate glycemic control with glucose level > 300 mg/dl within 24 hours of randomization
boolean
C0342299 (UMLS CUI [1])