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])
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])