ID

12603

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01800968

Stichworte

Versionen (1)
  1. 04.12.15 04.12.15 -
Hochgeladen am

4. Dezember 2015

DOI

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Eligibility Acute Heart Failure NCT01800968

Englisch

Eligibility Acute Heart Failure NCT01800968

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years
Beschreibung

age

Datentyp

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)
Beschreibung

acute heart failure

Datentyp

boolean

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

ahfs is the primary cause of hospitalization

Datentyp

boolean

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

prior clinical diagnosis of hf

Datentyp

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)
Beschreibung

left ventricular ejection fraction

Datentyp

boolean

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

evidence-based medication

Datentyp

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")
Beschreibung

loop diuretic or loop diuretic combined with a thiazide

Datentyp

boolean

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

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

ahfs due to acute myocarditis or acute myocardial infarction

Datentyp

boolean

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

significant arrhythmias

Datentyp

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.
Beschreibung

mechanical circulatory support

Datentyp

boolean

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

left ventricular assist device

Datentyp

boolean

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

Transplantation eligible

Datentyp

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)
Beschreibung

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

Datentyp

boolean

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

hemoglobin (hgb) < 8.0 g/dl

Datentyp

boolean

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

glomerular filtration rate

Datentyp

boolean

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

systolic blood pressure < 80 mmhg at consent

Datentyp

boolean

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

Tachycardia

Datentyp

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)
Beschreibung

acute coronary syndrome

Datentyp

boolean

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

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

Datentyp

boolean

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

primary hypertrophic cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0264847
infiltrative cardiomyopathy
Beschreibung

infiltrative cardiomyopathy

Datentyp

boolean

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

constrictive pericarditis

Datentyp

boolean

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

complex congenital heart disease

Datentyp

boolean

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

non-cardiac pulmonary edema

Datentyp

boolean

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

more than moderate aortic or mitral stenosis

Datentyp

boolean

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

valve disease

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

severe liver disease

Datentyp

boolean

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

life expectancy

Datentyp

boolean

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

adverse reaction

Datentyp

boolean

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

receipt of any investigational product in the previous 30 days

Datentyp

boolean

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

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

Datentyp

boolean

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

inability to comply with planned study procedures

Datentyp

boolean

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

pregnancy or breastfeeding

Datentyp

boolean

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

childbearing potential

Datentyp

boolean

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

pancreatitis

Datentyp

boolean

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

gastroparesis

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

weight-loss surgery

Datentyp

boolean

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

glp-1 receptor agonists

Datentyp

boolean

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

dipeptidyl peptide-iv inhibitor

Datentyp

boolean

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

thiazolidinedione

Datentyp

boolean

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

copd oxygen dependent

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

type 1 diabetes mellitus

Datentyp

boolean

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

inadequate glycemic control

Datentyp

boolean

Alias
UMLS CUI [1]
C0342299
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Ähnliche Modelle

Eligibility Acute Heart Failure NCT01800968

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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