ID

44329

Beschreibung

Renal Denervation in Heart Failure Patients With Preserved Ejection Fraction (RESPECT-HF); ODM derived from: https://clinicaltrials.gov/show/NCT02041130

Link

https://clinicaltrials.gov/show/NCT02041130

Stichworte

Versionen (2)
  1. 19.01.20 19.01.20 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02041130

Englisch

Eligibility Heart Failure NCT02041130

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with hfpef (based upon esc diagnostic criteria9)
Beschreibung

Heart failure with preserved ejection fraction [HFpEF]

Datentyp

boolean

Alias
UMLS CUI [1]
C4509226
1. symptoms and signs of heart failure; nyha class ii or higher
Beschreibung

Signs and Symptoms Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C1275491
2. left ventricular ejection fraction 50% or greater on echocardiography
Beschreibung

Left ventricular ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
3. echocardiographic evidence of left ventricular diastolic dysfunction (echo-doppler e/e' > 15 )and/or plasma ntprobnp > 220pg/ml.
Beschreibung

Left ventricular diastolic dysfunction Echocardiography | Doppler Echocardiography E/e' Ratio | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273070
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0013520
UMLS CUI [2,2]
C4288734
UMLS CUI [3]
C3272900
2. episode of acute decompensation (adhf)
Beschreibung

Episode of ADHF

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1609524
3. patients with and without background hypertension may be recruited. in the case of patients with background hypertension (ie history of fulfilling the diagnostic who criteria for hypertension: sbp > 140 mmhg and/or dbp > 90 mmhg) those with both controlled (<140/90mmhg by 24 hour ambulatory bp) and inadequately controlled bp (on 3 anti-hypertensive drugs including a diuretic) can be recruited.
Beschreibung

Background Hypertension | BackgroundHypertension Absent | Systolic Pressure | Diastolic blood pressure | Blood Pressure Controlled | Blood pressure inadequately controlled | Antihypertensive Agents Quantity | Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706907
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C1706907
UMLS CUI [2,2]
C0020538
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
UMLS CUI [5,1]
C0005823
UMLS CUI [5,2]
C2587213
UMLS CUI [6]
C0919892
UMLS CUI [7,1]
C0003364
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0012798
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known secondary cause of hypertension
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
2. renal artery stenosis >30% or anatomy otherwise unsuitable for rdn.
Beschreibung

Renal Artery Stenosis Percentage | Anatomy Inappropriate Renal artery denervation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0700276
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C3544270
3. heart failure with reduced lv ejection fraction (lvef < 50%).
Beschreibung

Heart failure with Reduced left ventricular ejection fraction | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C5232641
UMLS CUI [2]
C0428772
4. estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2 (mdrd calculation).
Beschreibung

GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1]
C2170215
5. systolic blood pressure < 105mmhg.
Beschreibung

Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
6. implanted pacemaker, prosthetic heart valve or other precluding cmr scanning.
Beschreibung

Pacemaker implant | Heart Valve Prosthesis | Factor Excludes MRI of Heart

Datentyp

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C0018825
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0412692
7. medical condition adversely affecting safety and/or effectiveness of the participant (including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or atrial fibrillation).
Beschreibung

Medical condition Affecting Patient safety | Medical condition Affecting Effectiveness | Peripheral Vascular Diseases | Aortic Aneurysm, Abdominal | Thrombocytopenia | Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1280519
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0162871
UMLS CUI [5]
C0040034
UMLS CUI [6]
C0004238
8. pregnant, nursing or planning to be pregnant.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
9. uncontrolled atrial fibrillation, ie with heart rate over 120 bpm
Beschreibung

ATRIAL FIBRILLATION UNCONTROLLED | Heart rate BPM

Datentyp

boolean

Alias
UMLS CUI [1]
C0741284
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0439385
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Ähnliche Modelle

Eligibility Heart Failure NCT02041130

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure with preserved ejection fraction [HFpEF]
Item
1. patients with hfpef (based upon esc diagnostic criteria9)
boolean
C4509226 (UMLS CUI [1])
Signs and Symptoms Heart failure New York Heart Association Classification
Item
1. symptoms and signs of heart failure; nyha class ii or higher
boolean
C0037088 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Left ventricular ejection fraction Echocardiography
Item
2. left ventricular ejection fraction 50% or greater on echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular diastolic dysfunction Echocardiography | Doppler Echocardiography E/e' Ratio | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
3. echocardiographic evidence of left ventricular diastolic dysfunction (echo-doppler e/e' > 15 )and/or plasma ntprobnp > 220pg/ml.
boolean
C1273070 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0013520 (UMLS CUI [2,1])
C4288734 (UMLS CUI [2,2])
C3272900 (UMLS CUI [3])
Episode of ADHF
Item
2. episode of acute decompensation (adhf)
boolean
C0332189 (UMLS CUI [1,1])
C1609524 (UMLS CUI [1,2])
Background Hypertension | BackgroundHypertension Absent | Systolic Pressure | Diastolic blood pressure | Blood Pressure Controlled | Blood pressure inadequately controlled | Antihypertensive Agents Quantity | Diuretics
Item
3. patients with and without background hypertension may be recruited. in the case of patients with background hypertension (ie history of fulfilling the diagnostic who criteria for hypertension: sbp > 140 mmhg and/or dbp > 90 mmhg) those with both controlled (<140/90mmhg by 24 hour ambulatory bp) and inadequately controlled bp (on 3 anti-hypertensive drugs including a diuretic) can be recruited.
boolean
C1706907 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C1706907 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
C0005823 (UMLS CUI [5,1])
C2587213 (UMLS CUI [5,2])
C0919892 (UMLS CUI [6])
C0003364 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0012798 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
1. known secondary cause of hypertension
boolean
C0155616 (UMLS CUI [1])
Renal Artery Stenosis Percentage | Anatomy Inappropriate Renal artery denervation
Item
2. renal artery stenosis >30% or anatomy otherwise unsuitable for rdn.
boolean
C0035067 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0700276 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C3544270 (UMLS CUI [2,3])
Heart failure with Reduced left ventricular ejection fraction | Left ventricular ejection fraction
Item
3. heart failure with reduced lv ejection fraction (lvef < 50%).
boolean
C0018801 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C5232641 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2])
GFR estimation by MDRD
Item
4. estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2 (mdrd calculation).
boolean
C2170215 (UMLS CUI [1])
Systolic Pressure
Item
5. systolic blood pressure < 105mmhg.
boolean
C0871470 (UMLS CUI [1])
Pacemaker implant | Heart Valve Prosthesis | Factor Excludes MRI of Heart
Item
6. implanted pacemaker, prosthetic heart valve or other precluding cmr scanning.
boolean
C0848753 (UMLS CUI [1])
C0018825 (UMLS CUI [2])
C1521761 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0412692 (UMLS CUI [3,3])
Medical condition Affecting Patient safety | Medical condition Affecting Effectiveness | Peripheral Vascular Diseases | Aortic Aneurysm, Abdominal | Thrombocytopenia | Atrial Fibrillation
Item
7. medical condition adversely affecting safety and/or effectiveness of the participant (including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or atrial fibrillation).
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0085096 (UMLS CUI [3])
C0162871 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
8. pregnant, nursing or planning to be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
ATRIAL FIBRILLATION UNCONTROLLED | Heart rate BPM
Item
9. uncontrolled atrial fibrillation, ie with heart rate over 120 bpm
boolean
C0741284 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0439385 (UMLS CUI [2,2])
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