ID

39492

Description

REDUCE LAP-HF TRIAL; ODM derived from: https://clinicaltrials.gov/show/NCT01913613

Link

https://clinicaltrials.gov/show/NCT01913613

Keywords

Versions (1)
  1. 1/17/20 1/17/20 -
Copyright Holder

See clinicaltrials.gov

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January 17, 2020

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01913613

English

Eligibility Heart Failure NCT01913613

1 forms  
Criteria
Description

Criteria

1. chronic symptomatic heart failure (hf) documented by one or more of the following:
Description

Chronic heart failure Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0231220
1. new york heart association (nyha) class ii/iii/ambulatory class iv symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;
Description

Symptoms New York Heart Association Classification | Symptoms Ambulatory New York Heart Association Classification | Paroxysmal nocturnal dyspnea | Orthopnea | Dyspnea on exertion Mild | Dyspnea on exertion Moderate | Signs | Rales Post Cough | Pulmonary congestion Chest X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1561561
UMLS CUI [2,3]
C1275491
UMLS CUI [3]
C1956415
UMLS CUI [4]
C0085619
UMLS CUI [5,1]
C0231807
UMLS CUI [5,2]
C2945599
UMLS CUI [6,1]
C0231807
UMLS CUI [6,2]
C0205081
UMLS CUI [7]
C0311392
UMLS CUI [8,1]
C0034642
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0010200
UMLS CUI [9,1]
C0242073
UMLS CUI [9,2]
C0039985
2. one hospital admission for which hf was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
Description

Hospitalization Due to Heart Failure Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
3. on-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 esc guidelines for diagnosis and treatment of acute and chronic heart failure).
Description

Pharmacotherapy Heart failure | Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0009488
2. age ≥ 40 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
Description

Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
4. elevated left ventricular filling pressures with a gradient compared to cvp documented by :
Description

Left ventricular filling pressure increased

Data type

boolean

Alias
UMLS CUI [1,1]
C1963871
UMLS CUI [1,2]
C0443246
1. pcwp or lvedp at rest ≥ 15 mmhg, and greater than cvp, or
Description

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level At rest

Data type

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2,1]
C0456190
UMLS CUI [2,2]
C0443144
2. pcwp during supine bike exercise ≥ 25mm hg, and cvp < 20 mm hg
Description

Pulmonary Capillary Wedge Pressure During Exercise stress test using supine bicycle | Measurement of central venous pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0086879
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2059698
UMLS CUI [2]
C0199666
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
3. severe heart failure defined as:
Description

Heart failure Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf;
Description

Heart failure Stage | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1306673
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
2. fick cardiac index < 2.0 l/min/m2
Description

Left ventricular Cardiac index by Fick method | Right ventricular Cardiac index by Fick method

Data type

boolean

Alias
UMLS CUI [1]
C0488670
UMLS CUI [2]
C0488679
3. requiring inotropic infusion (continuous or intermittent) within the past 6 months
Description

Requirement Inotropic agent Infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C0574032
4. patient is on the cardiac transplant waiting list 4. inability to perform 6 minute walk test 5. known significant coronary artery disease (stenosis >70%) 6. history of stroke, transient ischemic attack (tia), deep vein thrombosis (dvt), or pulmonary emboli within the past 6 months 7. known severe carotid artery stenosis (> 70%) 8. presence of significant valve disease defined by echocardiography as: a) mitral valve regurgitation defined as grade >2+ mr b) tricuspid valve regurgitation defined as grade ≥ 2+ tr; c) aortic valve disease defined as ≥ 2+ ar or moderate as
Description

Patient on waiting list Heart Transplantation | 6-Minute Walk Test Unable | Coronary Artery Disease | Stenosis Percentage | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism | Carotid Stenosis Severe Percentage | Valvular disease Echocardiography | Mitral Valve Insufficiency Grade | Tricuspid Valve Insufficiency Grade | Aortic valve disorder | Aortic Valve Insufficiency Grade | Aortic Valve Stenosis Moderate

Data type

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C1261287
UMLS CUI [4,2]
C0439165
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0149871
UMLS CUI [8]
C0034065
UMLS CUI [9,1]
C0007282
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0439165
UMLS CUI [10,1]
C3258293
UMLS CUI [10,2]
C0013516
UMLS CUI [11,1]
C0026266
UMLS CUI [11,2]
C0441800
UMLS CUI [12,1]
C0040961
UMLS CUI [12,2]
C0441800
UMLS CUI [13]
C1260873
UMLS CUI [14,1]
C0003504
UMLS CUI [14,2]
C0441800
UMLS CUI [15,1]
C0003507
UMLS CUI [15,2]
C0205081
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Similar models

Eligibility Heart Failure NCT01913613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Chronic heart failure Symptomatic
Item
1. chronic symptomatic heart failure (hf) documented by one or more of the following:
boolean
C0264716 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Symptoms New York Heart Association Classification | Symptoms Ambulatory New York Heart Association Classification | Paroxysmal nocturnal dyspnea | Orthopnea | Dyspnea on exertion Mild | Dyspnea on exertion Moderate | Signs | Rales Post Cough | Pulmonary congestion Chest X-ray
Item
1. new york heart association (nyha) class ii/iii/ambulatory class iv symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C1956415 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C0231807 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
C0231807 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
C0311392 (UMLS CUI [7])
C0034642 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0010200 (UMLS CUI [8,3])
C0242073 (UMLS CUI [9,1])
C0039985 (UMLS CUI [9,2])
Hospitalization Due to Heart Failure Quantity
Item
2. one hospital admission for which hf was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pharmacotherapy Heart failure | Comorbidity
Item
3. on-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 esc guidelines for diagnosis and treatment of acute and chronic heart failure).
boolean
C0013216 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
Age
Item
2. age ≥ 40 years old
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography
Item
3. left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular filling pressure increased
Item
4. elevated left ventricular filling pressures with a gradient compared to cvp documented by :
boolean
C1963871 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level At rest
Item
1. pcwp or lvedp at rest ≥ 15 mmhg, and greater than cvp, or
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
Pulmonary Capillary Wedge Pressure During Exercise stress test using supine bicycle | Measurement of central venous pressure
Item
2. pcwp during supine bike exercise ≥ 25mm hg, and cvp < 20 mm hg
boolean
C0086879 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2059698 (UMLS CUI [1,3])
C0199666 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Heart failure Severe
Item
3. severe heart failure defined as:
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart failure Stage | Heart failure New York Heart Association Classification
Item
1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf;
boolean
C0018801 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Left ventricular Cardiac index by Fick method | Right ventricular Cardiac index by Fick method
Item
2. fick cardiac index < 2.0 l/min/m2
boolean
C0488670 (UMLS CUI [1])
C0488679 (UMLS CUI [2])
Requirement Inotropic agent Infusion
Item
3. requiring inotropic infusion (continuous or intermittent) within the past 6 months
boolean
C1514873 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
Patient on waiting list Heart Transplantation | 6-Minute Walk Test Unable | Coronary Artery Disease | Stenosis Percentage | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism | Carotid Stenosis Severe Percentage | Valvular disease Echocardiography | Mitral Valve Insufficiency Grade | Tricuspid Valve Insufficiency Grade | Aortic valve disorder | Aortic Valve Insufficiency Grade | Aortic Valve Stenosis Moderate
Item
4. patient is on the cardiac transplant waiting list 4. inability to perform 6 minute walk test 5. known significant coronary artery disease (stenosis >70%) 6. history of stroke, transient ischemic attack (tia), deep vein thrombosis (dvt), or pulmonary emboli within the past 6 months 7. known severe carotid artery stenosis (> 70%) 8. presence of significant valve disease defined by echocardiography as: a) mitral valve regurgitation defined as grade >2+ mr b) tricuspid valve regurgitation defined as grade ≥ 2+ tr; c) aortic valve disease defined as ≥ 2+ ar or moderate as
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0430515 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3])
C1261287 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0149871 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
C0007282 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0439165 (UMLS CUI [9,3])
C3258293 (UMLS CUI [10,1])
C0013516 (UMLS CUI [10,2])
C0026266 (UMLS CUI [11,1])
C0441800 (UMLS CUI [11,2])
C0040961 (UMLS CUI [12,1])
C0441800 (UMLS CUI [12,2])
C1260873 (UMLS CUI [13])
C0003504 (UMLS CUI [14,1])
C0441800 (UMLS CUI [14,2])
C0003507 (UMLS CUI [15,1])
C0205081 (UMLS CUI [15,2])
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