ID

12603

Beskrivning

Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT); ODM derived from: https://clinicaltrials.gov/show/NCT01800968

Länk

https://clinicaltrials.gov/show/NCT01800968

Nyckelord

Versioner (1)
  1. 2015-12-04 2015-12-04 -
Uppladdad den

4 december 2015

DOI

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Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT01800968

Engelsk

Eligibility Acute Heart Failure NCT01800968

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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)
Beskrivning

acute heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0264714
ahfs is the primary cause of hospitalization
Beskrivning

ahfs is the primary cause of hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0019993
prior clinical diagnosis of hf
Beskrivning

prior clinical diagnosis of hf

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0011900
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)
Beskrivning

left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
on evidence-based medication for hf (including beta-blocker and ace-inhibitor/arb) or previously deemed intolerant
Beskrivning

evidence-based medication

Datatyp

boolean

Alias
UMLS CUI [1]
C1740791
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")
Beskrivning

loop diuretic or loop diuretic combined with a thiazide

Datatyp

boolean

Alias
UMLS CUI [1]
C0354100
UMLS CUI [2]
C3654030
willingness to provide informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
ahfs due to acute myocarditis or acute myocardial infarction
Beskrivning

ahfs due to acute myocarditis or acute myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0155626
2. ongoing hemodynamically significant arrhythmias contributing to hf decompensation
Beskrivning

significant arrhythmias

Datatyp

boolean

Alias
UMLS CUI [1]
C0003811
inotrope, intra-aortic balloon pump (iabp) or other mechanical circulatory support use at the time of consent. prior use will not exclude a patient.
Beskrivning

mechanical circulatory support

Datatyp

boolean

Alias
UMLS CUI [1]
C3274791
4. current or planned left ventricular assist device therapy in next 180 days
Beskrivning

left ventricular assist device

Datatyp

boolean

Alias
UMLS CUI [1]
C0181598
united network for organ sharing status 1a or 1b
Beskrivning

Transplantation eligible

Datatyp

boolean

Alias
UMLS CUI [1]
C0040732
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)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
hemoglobin (hgb) < 8.0 g/dl
Beskrivning

hemoglobin (hgb) < 8.0 g/dl

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
8. glomerular filtration rate(gfr) < 20 ml/min/1.73 m2 within 48 hours of consent
Beskrivning

glomerular filtration rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0017654
systolic blood pressure < 80 mmhg at consent
Beskrivning

systolic blood pressure < 80 mmhg at consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
resting heart rate > 110 at consent
Beskrivning

Tachycardia

Datatyp

boolean

Alias
UMLS CUI [1]
C0039231
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)
Beskrivning

acute coronary syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
Beskrivning

percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1322649
primary hypertrophic cardiomyopathy
Beskrivning

primary hypertrophic cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0264847
infiltrative cardiomyopathy
Beskrivning

infiltrative cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0878544
constrictive pericarditis or tamponade
Beskrivning

constrictive pericarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0031048
complex congenital heart disease
Beskrivning

complex congenital heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
non-cardiac pulmonary edema
Beskrivning

non-cardiac pulmonary edema

Datatyp

boolean

Alias
UMLS CUI [1]
C0034063
more than moderate aortic or mitral stenosis
Beskrivning

more than moderate aortic or mitral stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0155572
intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
Beskrivning

valve disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018824
sepsis, active infection (excluding cystitis) or other comorbidity driving the hf decompensation
Beskrivning

sepsis, active infection (excluding cystitis) or other comorbidity driving the hf decompensation

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0015127
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
Beskrivning

severe liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C3829821
terminal illness (other than hf) with expected survival of less than 1 year
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
previous adverse reaction to the study drug
Beskrivning

adverse reaction

Datatyp

boolean

Alias
UMLS CUI [1]
C0559546
receipt of any investigational product in the previous 30 days.
Beskrivning

receipt of any investigational product in the previous 30 days

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.
Beskrivning

enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
inability to comply with planned study procedures
Beskrivning

inability to comply with planned study procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
pregnancy or breastfeeding mothers
Beskrivning

pregnancy or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of reproductive age not on adequate contraception
Beskrivning

childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C1960468
history of acute or chronic pancreatitis
Beskrivning

pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
history of symptomatic gastroparesis
Beskrivning

gastroparesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0152020
familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (men2)
Beskrivning

familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (men2)

Datatyp

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C0025268
prior weight-loss surgery (i.e., roux-en-y gastric bypass) or other gastric surgery associated with increased endogenous glp-1 production
Beskrivning

weight-loss surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1456587
prior or ongoing treatment with glp-1 receptor agonists
Beskrivning

glp-1 receptor agonists

Datatyp

boolean

Alias
UMLS CUI [1]
C2917359
ongoing treatment with dipeptidyl peptide-iv inhibitors (1 week washout required)
Beskrivning

dipeptidyl peptide-iv inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C0081937
ongoing treatment with thiazolidinedione
Beskrivning

thiazolidinedione

Datatyp

boolean

Alias
UMLS CUI [1]
C1257987
oxygen-dependent chronic obstructive pulmonary disease
Beskrivning

copd oxygen dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C1737722
diabetic patients with history of 2 or more severe hypoglycemia, diabetic ketoacidosis(dka) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
Beskrivning

diabetic patients with history of 2 or more severe hypoglycemia, diabetic ketoacidosis(dka) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.

Datatyp

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020615
UMLS CUI [3]
C0020457
diagnosis of type 1 diabetes mellitus
Beskrivning

type 1 diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
if diabetic, inadequate glycemic control with glucose level > 300 mg/dl within 24 hours of randomization
Beskrivning

inadequate glycemic control

Datatyp

boolean

Alias
UMLS CUI [1]
C0342299
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Similar models

Eligibility Acute Heart Failure NCT01800968

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
prior clinical diagnosis of hf
Item
prior clinical diagnosis of hf
boolean
C0018801 (UMLS CUI [1])
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])
informed consent
Item
willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
pregnancy or breastfeeding
Item
pregnancy or breastfeeding mothers
boolean
C0032961 (UMLS CUI [1])
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])
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])
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])
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