Hospitalization Due to Decompensated cardiac failure | Inotropic agent Intravenous Patient need for | Vasodilator Agents Patient need for | Diuretic therapy Patient need for
Item
1. patients hospitalized due to decompensated heart failure who require iv inotropic and/or vasodilator and diuretic therapy
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,3])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0042402 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0948575 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Therapeutic procedure Appropriate Heart failure | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-Antagonists | intolerance to Angiotensin-Converting Enzyme Inhibitors | intolerance to Adrenergic beta-Antagonists | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Adrenergic beta-Antagonists | Diuretics
Item
2. patients receiving appropriate medical therapy for heart failure, defined as ace inhibitors and beta blockers (all unless not tolerated or contraindicated) and diuretics, for 1 month prior to study entry
boolean
C0087111 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0003015 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0001645 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0003015 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0001645 (UMLS CUI [7,2])
C0012798 (UMLS CUI [8])
Dobutamine Dosage Minimum | Milrinone Dosage Minimum | Dopamine Dosage Minimum | Nesiritide Dosage Minimum | Nitroglycerin Dosage Minimum
Item
3. for at least 24 hours prior to inclusion into the study, the patient should be treated with a minimum dose of the following: dobutamine 2.5μg/kg/min or milrinone 0.3μg/kg/min or dopamine 5μg/kg/min. or nesiritide 0.01μg/kg/min or nitroglycerin 0.3
boolean
C0012963 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0128513 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C0013030 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1524031 (UMLS CUI [3,3])
C0054015 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1524031 (UMLS CUI [4,3])
C0017887 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C1524031 (UMLS CUI [5,3])
Nitroprusside Dosage Minimum | Combined Modality Therapy | Diuretic therapy | Pharmaceutical Preparations Dosage Stable
Item
µg/kg/min or nitroprusside 0.3 µg/kg/min or a combination of any of these agents, with diuretic therapy. doses of the above stated medications should be stable for 6 hours prior to inclusion into study. an increase in this dosage within the first 8 hours after enrollment is determined by the attending physician to be unlikely and the following definition of "not responding adequately to iv inotropic and/or vasodilator and diuretic therapy" is exhibited:
boolean
C0028193 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0948575 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Pulmonary Capillary Wedge Pressure
Item
pcwp is ≥ 20 mmhg at time of randomization and pcwp was ≥ 18 mmhg continuously for 24 hours or pcwp ≥ 20 mmhg continuously for 12 hours prior to randomization.
boolean
C0086879 (UMLS CUI [1])
Cardiac index
Item
cardiac index < 2.4 l/min/m2
boolean
C0428776 (UMLS CUI [1])
Abnormal renal function Evidence of | Diuretic resistance | Creatinine measurement, serum | Furosemide Intravenous Daily Dose
Item
there is evidence for abnormal renal function and/or diuretic resistance defined as: serum creatinine > 1.2 mg/dl or diuretic dosage of intravenous furosemide ≥
boolean
C0151746 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2,1])
C0013203 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0016860 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C2348070 (UMLS CUI [4,3])
Furosemide Equivalent Intravenous Daily Dose
Item
120 mg daily, or equivalent
boolean
C0016860 (UMLS CUI [1,1])
C0205163 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,4])
Left ventricular ejection fraction
Item
4. lvef < 35%
boolean
C0428772 (UMLS CUI [1])
Age
Item
5. male or female 18-90 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Childbearing Potential | Pregnancy test negative
Item
6. if female, no child-bearing potential or negative pregnancy test
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0427780 (UMLS CUI [3])
Informed Consent
Item
7. written informed consent
boolean
C0021430 (UMLS CUI [1])
follow-up examination participation Willing
Item
8. willingness to participate in required follow-up exams
boolean
C0260832 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Q wave Related Myocardial Infarction
Item
1. acute q-wave myocardial infarction within past 7 days
boolean
C0429090 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
Cardiogenic Shock Post Cardiotomy
Item
2. post cardiotomy shock within past 30 days
boolean
C0036980 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0189758 (UMLS CUI [1,3])
Cardiac Surgery
Item
3. cardiac surgery within past 14 days
boolean
C0018821 (UMLS CUI [1])
Bridge Related Transplant
Item
4. bridge to transplant
boolean
C0456378 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Severe chronic obstructive pulmonary disease | FEV1
Item
5. history of severe copd as defined as fev1 < 1.0 liter
boolean
C0730607 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
Cardiac Arrhythmia
Item
6. history of malignant arrhythmias defined as either:
boolean
C0003811 (UMLS CUI [1])
Sustained ventricular tachycardia | Implantable defibrillator
Item
sustained ventricular tachycardia > 15 beats or more in length, not associated with a correctable cause, within the preceding 3 months, unless the patient presently has an implantable cardiac defibrillator.
boolean
C0750197 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Ventricular Fibrillation | Sudden death | Implantable defibrillator
Item
history of ventricular fibrillation or sudden death, unless the patient presently has an implantable cardiac defibrillator
boolean
C0042510 (UMLS CUI [1])
C0011071 (UMLS CUI [2])
C0162589 (UMLS CUI [3])
Cardiac Resynchronization Therapy Defibrillator Implantation
Item
7. patients implanted with a resynchronization device within the previous 14 days or if there is a possibility of implant within 60 days following randomization
boolean
C1322646 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Systolic Pressure
Item
8. systolic pressure <80 mmhg
boolean
C0871470 (UMLS CUI [1])
Cardiopulmonary resuscitator Patient need for
Item
9. requiring cardiopulmonary support type devices
boolean
C0183001 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Platelet Count measurement | Blood Coagulation Disorder Evidence of | International Normalized Ratio | Anticoagulation Therapy Absence
Item
10. platelets < 50,000/mm3 or other evidence of coagulopathy, inr greater than 1.5 in the absence of anticoagulation therapy.
boolean
C0032181 (UMLS CUI [1])
C0005779 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])
C0003281 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Communicable Diseases | White Blood Cell Count | Body temperature measurement
Item
11. infection (wbc ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°f/38°c)
boolean
C0009450 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0886414 (UMLS CUI [3])
Cerebrovascular accident | Transient Ischemic Attack
Item
12. history of cerebral vascular accident (cva) or transient ischemic attacks (tia) within the last 3 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Blood Transfusion Unwilling
Item
13. unwilling or unable to receive blood transfusion
boolean
C0005841 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Heparin therapy Unable
Item
14. inability to undergo treatment with heparin
boolean
C0522794 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Dialysis | Creatinine measurement, serum
Item
15. patients on dialysis or serum creatinine > 4.0 mg/dl
boolean
C0011946 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver disease Primary | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
16. primary liver disease with bilirubin, sgot, or sgpt > 4x upper limit of normal
boolean
C0023895 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Life Expectancy Due to Disease
Item
17. life expectancy from other disease < 12 months
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Patient on waiting list Heart Transplantation | Blood group O | Heart Transplantation Unlikely
Item
18. patients who are active on the cardiac transplantation waiting list, unless there is a documented reason (large body habitus, highly sensitized, o blood group) to anticipate that transplant is unlikely within the subsequent 65 days.
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0427625 (UMLS CUI [2])
C0018823 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
Patent Foramen Ovale Symptomatic | Shunt left-right intracardiac | Shunt right-left intracardiac
Item
19. symptomatic patent foramen ovale or intracardiac shunt
boolean
C0016522 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0489643 (UMLS CUI [2])
C0489644 (UMLS CUI [3])
Peripheral Vascular Disease Clinical Significance | Pedal pulse Absent | Limb ischemia Signs and Symptoms | Intermittent Claudication
Item
20. patients diagnosed with clinically significant peripheral vascular disease, defined as absent pedal pulse or signs or symptoms of limb ischemia, including a history of intermittent claudication
boolean
C0085096 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0232157 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2945695 (UMLS CUI [3,1])
C0037088 (UMLS CUI [3,2])
C0021775 (UMLS CUI [4])
Amyloidosis | Heart failure Due to Hyperthyroidism | High output heart failure Secondary to Arteriovenous fistula | Valvular disease Primary uncorrected Significant | Mitral Valve Insufficiency Secondary to Left ventricular dilatation
Item
21. patients with amyloidosis, thyroid induced heart failure, high output failure secondary to an arterio-venous fistula, and significant uncorrected primary valvular disease (with the exception of mitral regurgitation believed secondary to lv dilatation)
boolean
C0002726 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0020550 (UMLS CUI [2,3])
C0221045 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0003855 (UMLS CUI [3,3])
C3258293 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C4072785 (UMLS CUI [4,3])
C0750502 (UMLS CUI [4,4])
C0026266 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0344911 (UMLS CUI [5,3])