ID

35928

Beskrivning

HF Assessment With BNP in the Home: Part II; ODM derived from: https://clinicaltrials.gov/show/NCT02351063

Länk

https://clinicaltrials.gov/show/NCT02351063

Nyckelord

Versioner (1)
  1. 2019-04-04 2019-04-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02351063

Engelsk

Eligibility Heart Failure NCT02351063

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adults at least 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
2. willing to sign an informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. ambulatory subjects with worsening hf defined as:
Beskrivning

Study Subject Ambulatory | Heart failure Worsening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1561561
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0332271
1. admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated hf for which treatment will be administered; or
Beskrivning

Hospital admission | Therapy Outpatient clinic | Therapy Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0184666
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0002424
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0581377
2. seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of hf and with signs of worsening hf condition or decompensation, where worsening hf condition is defined as one or more of the following;
Beskrivning

Visit Outpatient clinic | Heart failure | Signs Heart failure Worsening | Signs Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C0002424
UMLS CUI [2]
C0018801
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C0018801
UMLS CUI [3,3]
C0332271
UMLS CUI [4,1]
C0311392
UMLS CUI [4,2]
C0581377
i. increase in nyha class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity
Beskrivning

Increase New York Heart Association Classification | Worsening Symptoms | Dyspnea | Fatigue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442805
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C1457887
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0015672
ii. symptoms requiring change in dosage of one or more hf medication.
Beskrivning

Symptoms Requirement Change in medication/dose | Pharmaceutical Preparations Quantity Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1608430
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0018801
iii. - physical evaluation consistent with worsening hf signs (i.e. elevated jugular vein pressure (jvp), ankle edema, dyspnea, abdominal distension, >4 lb. or >1.8 kg weight increase in past week)
Beskrivning

Evaluation Consistent with Heart failure Worsening | Raised jugular venous pressure | Ankle edema | Dyspnea | Abdomen distended | Weight Gain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0018801
UMLS CUI [1,4]
C0332271
UMLS CUI [2]
C0520861
UMLS CUI [3]
C0235439
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0000731
UMLS CUI [6]
C0043094
4. must have some documented evidence of their current lvef status as < 40% or > 40% (preferably a determination of %lvef) at the time they begin bnp self-testing or within 2 months of enrollment
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
5. at least one bnp value during the index hospitalization or within 2 weeks of the index visit to clinic with worsening hf that meet the following criteria
Beskrivning

Brain natriuretic peptide measurement Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C1265611
1. 400 pg/ml bnp (3200 pg/ml nt-probnp) for subjects diagnosed with hfref (lvsd < 40%) adjusted for bmi > 35
Beskrivning

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Heart failure with reduced ejection fraction [HFrEF] | Left ventricular systolic dysfunction | Adjustment Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
UMLS CUI [3]
C4509223
UMLS CUI [4]
C1277187
UMLS CUI [5,1]
C0456081
UMLS CUI [5,2]
C1305855
2. 300 pg/ml bnp (2400 pg/ml nt-probnp) for subjects diagnosed with hfpef (lvsd > 40%) adjusted for bmi > 35
Beskrivning

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Heart failure with preserved ejection fraction [HFpEF] | Left ventricular systolic dysfunction | Adjustment Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
UMLS CUI [3]
C4509226
UMLS CUI [4]
C1277187
UMLS CUI [5,1]
C0456081
UMLS CUI [5,2]
C1305855
6. deemed willing and suitable for heartcheck bnp home testing and participation in this study;
Beskrivning

Brain natriuretic peptide measurement Home Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0039593
7. successfully trained and deemed proficient on how to perform a fingerstick and to use the heartcheck system.
Beskrivning

Blood glucose determination by fingerstick | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C2022094
UMLS CUI [2]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. primary diagnosis at presentation of the index event of acute coronary syndrome (acs) (myocardial infarction (mi) or unstable angina).
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
2. prior heart transplant or planned transplant within the next 3 months
Beskrivning

Heart Transplantation | Transplantation Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1301732
3. current or planned use of left ventricular assist device (lvad) within 3 months
Beskrivning

Left ventricular assist device | Left ventricular assist device Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0181598
UMLS CUI [2,1]
C0181598
UMLS CUI [2,2]
C1301732
4. current or planned inotrope dependent therapy within 3 months
Beskrivning

Inotropic agent Dependence Therapy | Inotropic agent Dependence Therapy Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C0439857
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0439857
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1301732
5. current or planned percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) within 3 months
Beskrivning

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0010055
UMLS CUI [4,2]
C1301732
6. life expectancy less than 6 months for causes other than for cardiovascular reasons
Beskrivning

Life Expectancy | Cause Except Cardiovascular event

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1320716
7. end stage renal disease (estimated glomerular filtration rate (egfr) < 30 ml/min/1.73 m2)
Beskrivning

Kidney Failure, Chronic | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C3811844
8. other misc. cardiovascular and non-cardiovascular conditions such as amyloidosis, infiltrative cardiomyopathy, peripartum cardiomyopathy unless present for at least 12 months, acute myocarditis
Beskrivning

Cardiovascular Diseases | Other medical condition | Amyloidosis | Cardiomyopathy Infiltrating | Peripartum cardiomyopathy | Myocarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C3843040
UMLS CUI [3]
C0002726
UMLS CUI [4,1]
C0878544
UMLS CUI [4,2]
C0332448
UMLS CUI [5]
C0877208
UMLS CUI [6]
C0027059
9. receiving investigational medications or therapy
Beskrivning

Investigational New Drugs | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
10. hematocrit known to be outside the 25-50% range of the heartcheck system requirements
Beskrivning

Haematocrit abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0877168
11. deemed likely to be noncompliant with protocol by the investigator
Beskrivning

Protocol Compliance Unlikely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
12. residence in regions where transmission of test data or home visits are not possible
Beskrivning

Residence Remote | Home visit Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
UMLS CUI [2,1]
C0020043
UMLS CUI [2,2]
C1272705
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Similar models

Eligibility Heart Failure NCT02351063

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
1. adults at least 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. willing to sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
Study Subject Ambulatory | Heart failure Worsening
Item
3. ambulatory subjects with worsening hf defined as:
boolean
C0681850 (UMLS CUI [1,1])
C1561561 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
Hospital admission | Therapy Outpatient clinic | Therapy Decompensated cardiac failure
Item
1. admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated hf for which treatment will be administered; or
boolean
C0184666 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0002424 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0581377 (UMLS CUI [3,2])
Visit Outpatient clinic | Heart failure | Signs Heart failure Worsening | Signs Decompensated cardiac failure
Item
2. seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of hf and with signs of worsening hf condition or decompensation, where worsening hf condition is defined as one or more of the following;
boolean
C0008952 (UMLS CUI [1,1])
C0002424 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0311392 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0332271 (UMLS CUI [3,3])
C0311392 (UMLS CUI [4,1])
C0581377 (UMLS CUI [4,2])
Increase New York Heart Association Classification | Worsening Symptoms | Dyspnea | Fatigue
Item
i. increase in nyha class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity
boolean
C0442805 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0332271 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0013404 (UMLS CUI [3])
C0015672 (UMLS CUI [4])
Symptoms Requirement Change in medication/dose | Pharmaceutical Preparations Quantity Heart failure
Item
ii. symptoms requiring change in dosage of one or more hf medication.
boolean
C1457887 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Evaluation Consistent with Heart failure Worsening | Raised jugular venous pressure | Ankle edema | Dyspnea | Abdomen distended | Weight Gain
Item
iii. - physical evaluation consistent with worsening hf signs (i.e. elevated jugular vein pressure (jvp), ankle edema, dyspnea, abdominal distension, >4 lb. or >1.8 kg weight increase in past week)
boolean
C1261322 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0332271 (UMLS CUI [1,4])
C0520861 (UMLS CUI [2])
C0235439 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0000731 (UMLS CUI [5])
C0043094 (UMLS CUI [6])
Left ventricular ejection fraction
Item
4. must have some documented evidence of their current lvef status as < 40% or > 40% (preferably a determination of %lvef) at the time they begin bnp self-testing or within 2 months of enrollment
boolean
C0428772 (UMLS CUI [1])
Brain natriuretic peptide measurement Quantity
Item
5. at least one bnp value during the index hospitalization or within 2 weeks of the index visit to clinic with worsening hf that meet the following criteria
boolean
C1095989 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Heart failure with reduced ejection fraction [HFrEF] | Left ventricular systolic dysfunction | Adjustment Body mass index
Item
1. 400 pg/ml bnp (3200 pg/ml nt-probnp) for subjects diagnosed with hfref (lvsd < 40%) adjusted for bmi > 35
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
C4509223 (UMLS CUI [3])
C1277187 (UMLS CUI [4])
C0456081 (UMLS CUI [5,1])
C1305855 (UMLS CUI [5,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Heart failure with preserved ejection fraction [HFpEF] | Left ventricular systolic dysfunction | Adjustment Body mass index
Item
2. 300 pg/ml bnp (2400 pg/ml nt-probnp) for subjects diagnosed with hfpef (lvsd > 40%) adjusted for bmi > 35
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
C4509226 (UMLS CUI [3])
C1277187 (UMLS CUI [4])
C0456081 (UMLS CUI [5,1])
C1305855 (UMLS CUI [5,2])
Brain natriuretic peptide measurement Home Testing
Item
6. deemed willing and suitable for heartcheck bnp home testing and participation in this study;
boolean
C1095989 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Blood glucose determination by fingerstick | Other Coding
Item
7. successfully trained and deemed proficient on how to perform a fingerstick and to use the heartcheck system.
boolean
C2022094 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable
Item
1. primary diagnosis at presentation of the index event of acute coronary syndrome (acs) (myocardial infarction (mi) or unstable angina).
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Heart Transplantation | Transplantation Planned
Item
2. prior heart transplant or planned transplant within the next 3 months
boolean
C0018823 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Left ventricular assist device | Left ventricular assist device Planned
Item
3. current or planned use of left ventricular assist device (lvad) within 3 months
boolean
C0181598 (UMLS CUI [1])
C0181598 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Inotropic agent Dependence Therapy | Inotropic agent Dependence Therapy Planned
Item
4. current or planned inotrope dependent therapy within 3 months
boolean
C0304509 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304509 (UMLS CUI [2,1])
C0439857 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned
Item
5. current or planned percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) within 3 months
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0010055 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Life Expectancy | Cause Except Cardiovascular event
Item
6. life expectancy less than 6 months for causes other than for cardiovascular reasons
boolean
C0023671 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1320716 (UMLS CUI [2,3])
Kidney Failure, Chronic | Estimated Glomerular Filtration Rate
Item
7. end stage renal disease (estimated glomerular filtration rate (egfr) < 30 ml/min/1.73 m2)
boolean
C0022661 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Cardiovascular Diseases | Other medical condition | Amyloidosis | Cardiomyopathy Infiltrating | Peripartum cardiomyopathy | Myocarditis
Item
8. other misc. cardiovascular and non-cardiovascular conditions such as amyloidosis, infiltrative cardiomyopathy, peripartum cardiomyopathy unless present for at least 12 months, acute myocarditis
boolean
C0007222 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
C0002726 (UMLS CUI [3])
C0878544 (UMLS CUI [4,1])
C0332448 (UMLS CUI [4,2])
C0877208 (UMLS CUI [5])
C0027059 (UMLS CUI [6])
Investigational New Drugs | Therapy, Investigational
Item
9. receiving investigational medications or therapy
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Haematocrit abnormal
Item
10. hematocrit known to be outside the 25-50% range of the heartcheck system requirements
boolean
C0877168 (UMLS CUI [1])
Protocol Compliance Unlikely
Item
11. deemed likely to be noncompliant with protocol by the investigator
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Residence Remote | Home visit Unsuccessful
Item
12. residence in regions where transmission of test data or home visits are not possible
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
C0020043 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
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