Age
Item
1. male or female patients, age 18 years or more
boolean
C0001779 (UMLS CUI [1])
Decompensated chronic heart failure | Decompensated chronic heart failure Ischemic | Hospitalization Patient need for | Furosemide | torsemide | Bumetanide | Therapeutic procedure Optimal Heart failure | Congestive heart failure
Item
2. a diagnosis of acute or subacute decompensated chronic heart failure, either ischemic or nonischemic, requiring hospitalization, and currently treated with furosemide, torsemide, or bumetadine, and other evidence based optimal treatment for heart failure. patients must have the clinical diagnosis of chf made at least 3 month prior to enrollment
boolean
C1827266 (UMLS CUI [1])
C1827266 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0016860 (UMLS CUI [4])
C0076840 (UMLS CUI [5])
C0006376 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C2698651 (UMLS CUI [7,2])
C0018801 (UMLS CUI [7,3])
C0018802 (UMLS CUI [8])
Ambulatory
Item
3. ambulatory
boolean
C0439841 (UMLS CUI [1])
Left Ventricular Dysfunction Signs | Left ventricular ejection fraction
Item
4. objective signs of lvd corresponding to a lvef < 45%, documented by any accepted method within the previous 12 months. if documentation is not available within the required time frame, lvef must be assessed prior to enrollment
boolean
C0242698 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Heart failure Symptoms Worsening New York Heart Association Classification
Item
5. a) worsening heart failure symptoms (current nyha class iii-iv). patients must experience worsening of at least one of the symptoms described below at the time of entry into the study:
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
C1275491 (UMLS CUI [1,4])
Dyspnea Symptoms
Item
dyspnea symptoms:
boolean
C0013404 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Resting Dyspnea
Item
dyspnea (labored or difficult breathing) at rest
boolean
C0743330 (UMLS CUI [1])
Dyspnea on exertion Minimal Worsening
Item
worsening dyspnea (labored or difficult breathing) on minimal exertion
boolean
C0231807 (UMLS CUI [1,1])
C0547040 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
Orthopnea Worsening
Item
worsening orthopnea (difficult breathing except in the upright position)
boolean
C0085619 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
nocturnal dyspnea causing awakening from sleep Frequency Increased | Respiratory distress
Item
increased frequency of nocturnal dyspnea (awaken from sleep due to respiratory distress)
boolean
C2367500 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0476273 (UMLS CUI [2])
clinical symptoms of volume overload | Weight Gain | Peripheral edema | Hepatic congestion | Ascites | Pulmonary congestion | Pleural effusion
Item
b) clinical evidence of volume overload such as weight gain over previous few days, peripheral edema, hepatic congestion with ascites, pulmonary congestion, or pleural effusion
boolean
C2236137 (UMLS CUI [1])
C0043094 (UMLS CUI [2])
C0085649 (UMLS CUI [3])
C0267821 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C0242073 (UMLS CUI [6])
C0032227 (UMLS CUI [7])
Childbearing Potential Pregnancy test negative | Postmenopausal state | Uterus Absent | Both ovaries Absent
Item
6. females of childbearing potential must have a negative pregnancy test at enrollment. a female is considered to be of childbearing potential unless she is post-menopausal (no menses for at least 12 consecutive months) or without a uterus and/or both ovaries
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0042149 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0227898 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent
Item
7. ability to understand and willing to sign informed consent form
boolean
C0021430 (UMLS CUI [1])
Condition 6-minute walk test Unable | Heart failure | Impairment Muscular | Impairment Skeletal
Item
1. incapable of taking the 6-minute walk test due to any condition unrelated to heart failure, e.g., muscular or skeletal disability
boolean
C0348080 (UMLS CUI [1,1])
C0430515 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2])
C0221099 (UMLS CUI [3,1])
C0442025 (UMLS CUI [3,2])
C0221099 (UMLS CUI [4,1])
C0521324 (UMLS CUI [4,2])
Heart valve disease Requirement Operative Surgical Procedure | Heart failure Due to Primary valvular heart disease uncorrected | Artificial heart valve Malfunction | Congenital heart disease uncorrected
Item
2. valvular heart disease requiring surgical intervention (during the course of the study. patients with heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease)
boolean
C0018824 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C2064629 (UMLS CUI [2,3])
C4072785 (UMLS CUI [2,4])
C1399223 (UMLS CUI [3,1])
C0086138 (UMLS CUI [3,2])
C0152021 (UMLS CUI [4,1])
C4072785 (UMLS CUI [4,2])
Disease Severe Excludes Participation | Disease Severe Complicating Evaluation Research results
Item
3. history of or clinically significant evidence of any severe disease other than heart failure that preclude participation and complicate the evaluation of study results from the local laboratory:
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1522701 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
C0683954 (UMLS CUI [2,5])
Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Kidney Disease | Creatinine measurement, serum
Item
hepatic disease (ast, alt, total bilirubin > 3 times upper limit of normal (uln), renal disease (s-creatinine > 2.5 mg/dl),
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | Hypoglycaemic episode Frequent | Hospitalization Frequent Hyperglycemia
Item
uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemic episodes or frequent hospitalizations for hyperglycemia,
boolean
C0743113 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C0332183 (UMLS CUI [3,2])
C0020456 (UMLS CUI [3,3])
Malignant Neoplasms | Skin carcinoma Treated
Item
cancer (excluding treated non-melanoma skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Angina, Unstable | Shock, Cardiogenic | Pulmonary Edema Requirement Therapeutic procedure | Nitroprusside | Nitroglycerin Intravenous | Nesiritide | Inotropic agent Intravenous | Intubation, Intratracheal | Mechanical ventilation
Item
4. unstable angina, cardiogenic shock, or acute pulmonary edema requiring any of the following: nitroprusside, intravenous nitroglycerin, nesiritide, intravenous inotrope, or need for endotracheal intubation and mechanical ventilation
boolean
C0002965 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
C0034063 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0028193 (UMLS CUI [4])
C0017887 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C0054015 (UMLS CUI [6])
C0304509 (UMLS CUI [7,1])
C1522726 (UMLS CUI [7,2])
C0021932 (UMLS CUI [8])
C0199470 (UMLS CUI [9])
Myocardial Infarction Symptoms | Electrocardiography | Injury Heart Biochemical Marker
Item
5. acute myocardial infarction and/or myocardial infarction within 30 days (prior to enrollment) as diagnosed by investigator’s evaluation of clinical symptoms, ecg, and/or biochemical markers of cardiac injury
boolean
C0027051 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
C3263723 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0206015 (UMLS CUI [3,3])
Cardiac Arrest | Myocardial Infarction | Catheter placement | Electrolytes abnormal Transitory Severe | Cardiac Electrophysiology | Automatic Implantable Cardioverter-Defibrillator Implantation | Cardiac Arrest Risk Increased | qtc interval | Second degree atrioventricular block | Complete atrioventricular block
Item
6. cardiac arrest (patients with history of cardiac arrest within 12 months unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, severe transient electrolyte abnormality, by an electrophysiology procedure, or addressed by automatic implantable cardioverter defibrillator placement. patients with increased risk of cardiac arrest, qtc > 450 msec, atrial ventricular block ii or iii, etc.)
boolean
C0018790 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0883301 (UMLS CUI [3])
C0151613 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0430467 (UMLS CUI [5])
C0972395 (UMLS CUI [6,1])
C0021107 (UMLS CUI [6,2])
C0018790 (UMLS CUI [7,1])
C0035647 (UMLS CUI [7,2])
C0205217 (UMLS CUI [7,3])
C0489625 (UMLS CUI [8])
C0264906 (UMLS CUI [9])
C0151517 (UMLS CUI [10])
Ventricular Tachycardia Sustain Ability | Ventricular Fibrillation Sustain Ability | Ventricular Premature Complex by ECG Associated with Symptoms | Ventricular Tachycardia Beat Quantity
Item
7. sustainable vt/vf within 30 days (> 15 seconds long; patients with enrollment ecg showing ventricular tachycardia or premature ventricular complexes associated with symptoms, or ventricular tachycardia of 6 beats)
boolean
C0042514 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0042510 (UMLS CUI [2,1])
C0443318 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C3714652 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C1457887 (UMLS CUI [3,3])
C0042514 (UMLS CUI [4,1])
C0425583 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
UNCONTROLLED ATRIAL FIBRILLATION Electrocardiogram: ventricular rate
Item
8. uncontrolled atrial fibrillation on enrollment ecg with a ventricular rate >120 bpm
boolean
C0741284 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
Cardiac Surgery procedures | Percutaneous Coronary Intervention Patient need for | Myocardial Revascularization | Valve Operative Surgical Procedures | Cardiac Resynchronization biventricular | Ventricular reduction surgery | Myoplasty cardiac | Ventricular assist device
Item
9. cardiac surgery within the last month or acutely required pci (patients who have undergone a cardiac revascularization, valvular surgery, or biventricular resynchronization procedure within 30 days. patients who have had ventricular reduction surgery or cardiac myoplasty and patients with mechanical ventricular assist device)
boolean
C0018821 (UMLS CUI [1])
C1532338 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0027056 (UMLS CUI [3])
C1186983 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C1167956 (UMLS CUI [5,1])
C0699808 (UMLS CUI [5,2])
C1955770 (UMLS CUI [6])
C0185414 (UMLS CUI [7,1])
C0018787 (UMLS CUI [7,2])
C0085842 (UMLS CUI [8])
Systolic Pressure
Item
10. systolic blood pressure < 90 mmhg and > 200 mmhg
boolean
C0871470 (UMLS CUI [1])
Pulmonary Embolism | Deep Vein Thrombosis
Item
11. pulmonary embolism or dvt or history of pulmonary embolism or dvt within 6 months prior to enrollment
boolean
C0034065 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Obstructive Lung Disease Severe | Restrictive pulmonary disease Severe | Idiopathic pulmonary hypertension | Heart failure Secondary to Lung disease | Infectious disease of lung Severe
Item
12. severe obstructive or restrictive pulmonary disease, patients with primary pulmonary hypertension and heart failure secondary to pulmonary disease, and severe pulmonary infection
boolean
C0600260 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877013 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0152171 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0024115 (UMLS CUI [4,3])
C0876973 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Vasoactive agent Intravenous | Vasodilator Agents | Inotropic agent Positive
Item
13. i.v. vasoactive treatment, e.g. vasodilators, positive inotropic agents, within 24 hours prior to enrollment (see details in appendix e)
boolean
C0597639 (UMLS CUI [1,1])
C0348016 (UMLS CUI [1,2])
C0042402 (UMLS CUI [2])
C0304509 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Study Subject Participation Status | Experimental therapy Biases Research results
Item
14. participation in another study evaluating an experimental treatment within the last 30 days which potentially could bias the outcome of this study
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2,1])
C0242568 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
ZP120
Item
15. previous treatment with zp120
boolean
C1176012 (UMLS CUI [1])
Alcohol abuse | Illicit Drugs abuse | Ethanol U/day | Beer Quantity per day | Wine Quantity per day | Spirits Quantity per day
Item
16. patients known to abuse or actively abusing alcohol or illicit drugs. abuse of alcohol is defined as the usual daily intake of more than 100 grams of ethanol per day, or more than approximately six 12-ounce bottles of beer, one 750 ml bottle of wine, or 250 ml of 80 proof spirits
boolean
C0085762 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0001962 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0004922 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0439505 (UMLS CUI [4,3])
C0043188 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0439505 (UMLS CUI [5,3])
C0301611 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0439505 (UMLS CUI [6,3])
Informed Consent Unable | Informed Consent Unwilling
Item
17. inability or unwillingness to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Body mass index
Item
18. bmi outside range of 20-50 kg/m2 (bmi equal to 20 and 50 kg/m2 is accepted)
boolean
C1305855 (UMLS CUI [1])
Condition Study Subject Participation Status Inappropriate | Therapeutic procedure Study Subject Participation Status Inappropriate
Item
19. any other condition or therapy, which in the opinion of the principal investigator would make the patient unsuitable for this study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])