ID

35962

Beskrivning

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction; ODM derived from: https://clinicaltrials.gov/show/NCT01920711

Länk

https://clinicaltrials.gov/show/NCT01920711

Nyckelord

Versioner (1)
  1. 2019-04-06 2019-04-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure With Preserved Ejection Fraction NCT01920711

Engelsk

Eligibility Heart Failure With Preserved Ejection Fraction NCT01920711

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
left ventricular ejection fraction (lvef) ≥45% prior to study entry.
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
symptom(s) of heart failure (hf) and requiring treatment with diuretic(s) for hf ≥30 days prior to study entry
Beskrivning

Symptoms Heart failure | Requirement Diuretics Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0012798
UMLS CUI [2,3]
C0018801
current symptom(s) of hf
Beskrivning

Symptoms Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018801
structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
Beskrivning

Structural disorder of heart Echocardiography | Left atrial hypertrophy Echocardiography | Left Ventricular Hypertrophy Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1290384
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0238705
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0149721
UMLS CUI [3,2]
C0013516
at least one of the following: a hf hospitalization within 9 months prior to study entry and/or an elevated nt-probnp.
Beskrivning

Hospitalization Due to Heart Failure | NT-proBNP increased

Datatyp

boolean

Alias
UMLS CUI [1]
C3898876
UMLS CUI [2]
C3203735
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior measurement of lvef < 45%.
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
acute coronary syndrome (including mi), cardiac surgery, other major cv surgery within 3 months , or urgent percutaneous coronary intervention (pci) within 30 days of entry.
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction | Cardiac Surgery procedures | Cardiovascular Surgical Procedures Major | Percutaneous Coronary Intervention Urgent

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018821
UMLS CUI [4,1]
C0038897
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C1532338
UMLS CUI [5,2]
C0439609
patients who have had an mi, coronary artery bypass graft (cabg) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a lvef ≥45%.
Beskrivning

Myocardial Infarction | Coronary Artery Bypass Surgery | Event | Exception Left ventricular ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0441471
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0428772
UMLS CUI [4,3]
C0013516
current acute decompensated hf requiring therapy.
Beskrivning

Decompensated cardiac failure Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0332121
patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (acei), an angiotensin receptor blocker (arb) or a renin inhibitor
Beskrivning

Patient need for Angiotensin-Converting Enzyme Inhibitors | Patient need for Angiotensin II receptor antagonist | Patient need for Renin-inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0521942
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C3653375
alternative reason for shortness of breath such as: significant pulmonary disease or severe copd, hemoglobin (hgb) <10 g/dl, or body mass index (bmi) > 40 kg/m2.
Beskrivning

Dyspnea Etiology aspects | Lung disease | Severe chronic obstructive pulmonary disease | Hemoglobin measurement | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0730607
UMLS CUI [4]
C0518015
UMLS CUI [5]
C1305855
systolic blood pressure (sbp) ≥ 180 mmhg at entry, or sbp >150 mmhg and <180 mmhg at entry unless the patient is receiving 3 or more antihypertensive drugs.
Beskrivning

Systolic Pressure | Exception Antihypertensive Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003364
UMLS CUI [2,3]
C1265611
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Heart Failure With Preserved Ejection Fraction NCT01920711

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≥45% prior to study entry.
boolean
C0428772 (UMLS CUI [1])
Symptoms Heart failure | Requirement Diuretics Heart failure
Item
symptom(s) of heart failure (hf) and requiring treatment with diuretic(s) for hf ≥30 days prior to study entry
boolean
C1457887 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0012798 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Symptoms Heart failure
Item
current symptom(s) of hf
boolean
C1457887 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Structural disorder of heart Echocardiography | Left atrial hypertrophy Echocardiography | Left Ventricular Hypertrophy Echocardiography
Item
structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
boolean
C1290384 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0238705 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0149721 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
Hospitalization Due to Heart Failure | NT-proBNP increased
Item
at least one of the following: a hf hospitalization within 9 months prior to study entry and/or an elevated nt-probnp.
boolean
C3898876 (UMLS CUI [1])
C3203735 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Left ventricular ejection fraction
Item
any prior measurement of lvef < 45%.
boolean
C0428772 (UMLS CUI [1])
Acute Coronary Syndrome | Myocardial Infarction | Cardiac Surgery procedures | Cardiovascular Surgical Procedures Major | Percutaneous Coronary Intervention Urgent
Item
acute coronary syndrome (including mi), cardiac surgery, other major cv surgery within 3 months , or urgent percutaneous coronary intervention (pci) within 30 days of entry.
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
C0038897 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C1532338 (UMLS CUI [5,1])
C0439609 (UMLS CUI [5,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Event | Exception Left ventricular ejection fraction Echocardiography
Item
patients who have had an mi, coronary artery bypass graft (cabg) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a lvef ≥45%.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0441471 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0428772 (UMLS CUI [4,2])
C0013516 (UMLS CUI [4,3])
Decompensated cardiac failure Treatment required for
Item
current acute decompensated hf requiring therapy.
boolean
C0581377 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Patient need for Angiotensin-Converting Enzyme Inhibitors | Patient need for Angiotensin II receptor antagonist | Patient need for Renin-inhibitors
Item
patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (acei), an angiotensin receptor blocker (arb) or a renin inhibitor
boolean
C0686904 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C3653375 (UMLS CUI [3,2])
Dyspnea Etiology aspects | Lung disease | Severe chronic obstructive pulmonary disease | Hemoglobin measurement | Body mass index
Item
alternative reason for shortness of breath such as: significant pulmonary disease or severe copd, hemoglobin (hgb) <10 g/dl, or body mass index (bmi) > 40 kg/m2.
boolean
C0013404 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0730607 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C1305855 (UMLS CUI [5])
Systolic Pressure | Exception Antihypertensive Agents Quantity
Item
systolic blood pressure (sbp) ≥ 180 mmhg at entry, or sbp >150 mmhg and <180 mmhg at entry unless the patient is receiving 3 or more antihypertensive drugs.
boolean
C0871470 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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