ID

20881

Description

ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00283361

Lien

https://clinicaltrials.gov/show/NCT00283361

Mots-clés

Versions (1)
  1. 24/03/2017 24/03/2017 -
Téléchargé le

24 mars 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00283361

Anglais

Eligibility Heart Failure, Congestive NCT00283361

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients, age 18 years or more
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Decompensated chronic heart failure | Decompensated chronic heart failure Ischemic | Hospitalization Patient need for | Furosemide | torsemide | Bumetanide | Therapeutic procedure Optimal Heart failure | Congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C1827266
UMLS CUI [2,1]
C1827266
UMLS CUI [2,2]
C0475224
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0686904
UMLS CUI [4]
C0016860
UMLS CUI [5]
C0076840
UMLS CUI [6]
C0006376
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C2698651
UMLS CUI [7,3]
C0018801
UMLS CUI [8]
C0018802
3. ambulatory
Description

Ambulatory

Type de données

boolean

Alias
UMLS CUI [1]
C0439841
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
Description

Left Ventricular Dysfunction Signs | Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242698
UMLS CUI [1,2]
C0311392
UMLS CUI [2]
C0428772
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:
Description

Heart failure Symptoms Worsening New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332271
UMLS CUI [1,4]
C1275491
dyspnea symptoms:
Description

Dyspnea Symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C1457887
dyspnea (labored or difficult breathing) at rest
Description

Resting Dyspnea

Type de données

boolean

Alias
UMLS CUI [1]
C0743330
worsening dyspnea (labored or difficult breathing) on minimal exertion
Description

Dyspnea on exertion Minimal Worsening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231807
UMLS CUI [1,2]
C0547040
UMLS CUI [1,3]
C0332271
worsening orthopnea (difficult breathing except in the upright position)
Description

Orthopnea Worsening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085619
UMLS CUI [1,2]
C0332271
increased frequency of nocturnal dyspnea (awaken from sleep due to respiratory distress)
Description

nocturnal dyspnea causing awakening from sleep Frequency Increased | Respiratory distress

Type de données

boolean

Alias
UMLS CUI [1,1]
C2367500
UMLS CUI [1,2]
C0376249
UMLS CUI [1,3]
C0205217
UMLS CUI [2]
C0476273
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
Description

clinical symptoms of volume overload | Weight Gain | Peripheral edema | Hepatic congestion | Ascites | Pulmonary congestion | Pleural effusion

Type de données

boolean

Alias
UMLS CUI [1]
C2236137
UMLS CUI [2]
C0043094
UMLS CUI [3]
C0085649
UMLS CUI [4]
C0267821
UMLS CUI [5]
C0003962
UMLS CUI [6]
C0242073
UMLS CUI [7]
C0032227
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
Description

Childbearing Potential Pregnancy test negative | Postmenopausal state | Uterus Absent | Both ovaries Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0042149
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0227898
UMLS CUI [4,2]
C0332197
7. ability to understand and willing to sign informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. incapable of taking the 6-minute walk test due to any condition unrelated to heart failure, e.g., muscular or skeletal disability
Description

Condition 6-minute walk test Unable | Heart failure | Impairment Muscular | Impairment Skeletal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0430515
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0018801
UMLS CUI [3,1]
C0221099
UMLS CUI [3,2]
C0442025
UMLS CUI [4,1]
C0221099
UMLS CUI [4,2]
C0521324
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)
Description

Heart valve disease Requirement Operative Surgical Procedure | Heart failure Due to Primary valvular heart disease uncorrected | Artificial heart valve Malfunction | Congenital heart disease uncorrected

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C2064629
UMLS CUI [2,4]
C4072785
UMLS CUI [3,1]
C1399223
UMLS CUI [3,2]
C0086138
UMLS CUI [4,1]
C0152021
UMLS CUI [4,2]
C4072785
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:
Description

Disease Severe Excludes Participation | Disease Severe Complicating Evaluation Research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0679823
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1522701
UMLS CUI [2,4]
C1261322
UMLS CUI [2,5]
C0683954
hepatic disease (ast, alt, total bilirubin > 3 times upper limit of normal (uln), renal disease (s-creatinine > 2.5 mg/dl),
Description

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Kidney Disease | Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0741494
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0201976
uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemic episodes or frequent hospitalizations for hyperglycemia,
Description

DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | Hypoglycaemic episode Frequent | Hospitalization Frequent Hyperglycemia

Type de données

boolean

Alias
UMLS CUI [1]
C0743113
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0332183
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0332183
UMLS CUI [3,3]
C0020456
cancer (excluding treated non-melanoma skin cancer)
Description

Malignant Neoplasms | Skin carcinoma Treated

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
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
Description

Angina, Unstable | Shock, Cardiogenic | Pulmonary Edema Requirement Therapeutic procedure | Nitroprusside | Nitroglycerin Intravenous | Nesiritide | Inotropic agent Intravenous | Intubation, Intratracheal | Mechanical ventilation

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0036980
UMLS CUI [3,1]
C0034063
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C0028193
UMLS CUI [5,1]
C0017887
UMLS CUI [5,2]
C1522726
UMLS CUI [6]
C0054015
UMLS CUI [7,1]
C0304509
UMLS CUI [7,2]
C1522726
UMLS CUI [8]
C0021932
UMLS CUI [9]
C0199470
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
Description

Myocardial Infarction Symptoms | Electrocardiography | Injury Heart Biochemical Marker

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C1623258
UMLS CUI [3,1]
C3263723
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0206015
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.)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0018790
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0883301
UMLS CUI [4,1]
C0151613
UMLS CUI [4,2]
C0205374
UMLS CUI [4,3]
C0205082
UMLS CUI [5]
C0430467
UMLS CUI [6,1]
C0972395
UMLS CUI [6,2]
C0021107
UMLS CUI [7,1]
C0018790
UMLS CUI [7,2]
C0035647
UMLS CUI [7,3]
C0205217
UMLS CUI [8]
C0489625
UMLS CUI [9]
C0264906
UMLS CUI [10]
C0151517
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)
Description

Ventricular Tachycardia Sustain Ability | Ventricular Fibrillation Sustain Ability | Ventricular Premature Complex by ECG Associated with Symptoms | Ventricular Tachycardia Beat Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C0443318
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0042510
UMLS CUI [2,2]
C0443318
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C3714652
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C1457887
UMLS CUI [4,1]
C0042514
UMLS CUI [4,2]
C0425583
UMLS CUI [4,3]
C1265611
8. uncontrolled atrial fibrillation on enrollment ecg with a ventricular rate >120 bpm
Description

UNCONTROLLED ATRIAL FIBRILLATION Electrocardiogram: ventricular rate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0741284
UMLS CUI [1,2]
C2189285
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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0686904
UMLS CUI [3]
C0027056
UMLS CUI [4,1]
C1186983
UMLS CUI [4,2]
C0543467
UMLS CUI [5,1]
C1167956
UMLS CUI [5,2]
C0699808
UMLS CUI [6]
C1955770
UMLS CUI [7,1]
C0185414
UMLS CUI [7,2]
C0018787
UMLS CUI [8]
C0085842
10. systolic blood pressure < 90 mmhg and > 200 mmhg
Description

Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
11. pulmonary embolism or dvt or history of pulmonary embolism or dvt within 6 months prior to enrollment
Description

Pulmonary Embolism | Deep Vein Thrombosis

Type de données

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0149871
12. severe obstructive or restrictive pulmonary disease, patients with primary pulmonary hypertension and heart failure secondary to pulmonary disease, and severe pulmonary infection
Description

Obstructive Lung Disease Severe | Restrictive pulmonary disease Severe | Idiopathic pulmonary hypertension | Heart failure Secondary to Lung disease | Infectious disease of lung Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0877013
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0152171
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0024115
UMLS CUI [5,1]
C0876973
UMLS CUI [5,2]
C0205082
13. i.v. vasoactive treatment, e.g. vasodilators, positive inotropic agents, within 24 hours prior to enrollment (see details in appendix e)
Description

Vasoactive agent Intravenous | Vasodilator Agents | Inotropic agent Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C0348016
UMLS CUI [2]
C0042402
UMLS CUI [3,1]
C0304509
UMLS CUI [3,2]
C1514241
14. participation in another study evaluating an experimental treatment within the last 30 days which potentially could bias the outcome of this study
Description

Study Subject Participation Status | Experimental therapy Biases Research results

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0242568
UMLS CUI [2,3]
C0683954
15. previous treatment with zp120
Description

ZP120

Type de données

boolean

Alias
UMLS CUI [1]
C1176012
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
Description

Alcohol abuse | Illicit Drugs abuse | Ethanol U/day | Beer Quantity per day | Wine Quantity per day | Spirits Quantity per day

Type de données

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0013146
UMLS CUI [3,1]
C0001962
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0004922
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0439505
UMLS CUI [5,1]
C0043188
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0439505
UMLS CUI [6,1]
C0301611
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0439505
17. inability or unwillingness to provide informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
18. bmi outside range of 20-50 kg/m2 (bmi equal to 20 and 50 kg/m2 is accepted)
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
19. any other condition or therapy, which in the opinion of the principal investigator would make the patient unsuitable for this study
Description

Condition Study Subject Participation Status Inappropriate | Therapeutic procedure Study Subject Participation Status Inappropriate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
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Similar models

Eligibility Heart Failure, Congestive NCT00283361

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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