ID

40131

Beskrivning

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01850901

Länk

https://clinicaltrials.gov/show/NCT01850901

Nyckelord

Versioner (1)
  1. 2020-03-13 2020-03-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT01850901

Engelsk

Eligibility Hypertension NCT01850901

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. individual has a mean day-time sbp ≥ 135 mmhg, as determined with the use of abpm, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ace/arb, calcium channel blocker, beta blocker, diuretic) and no possibility to take 3 anti-hypertensive drugs.
Beskrivning

Systolic Pressure Daytime mean | Blood Pressure Monitoring, Ambulatory | Antihypertensive Agents Quantity | Intolerance to Antihypertensive Agents Quantity | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Calcium Channel Blockers | Adrenergic beta-1 Receptor Antagonists | Diuretics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0332169
UMLS CUI [1,3]
C0444504
UMLS CUI [2]
C0242876
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003364
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C0003015
UMLS CUI [6]
C0521942
UMLS CUI [7]
C0006684
UMLS CUI [8]
C0304516
UMLS CUI [9]
C0012798
2. individual is ≥18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. individual is unable or unwilling to sign informed consent.
Beskrivning

Informed Consent Unable | Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
2. individual has a treatable secondary cause of hypertension.
Beskrivning

Cause Secondary to Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0020538
3. individual has an egfr below 20 ml/min/1.73m2 using the modification of diet in renal disease (mdrd) calculation.
Beskrivning

GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C2170215
4. individual has renal artery anatomy that is ineligible for treatment
Beskrivning

Renal artery Anatomy Ineligible Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
5. individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
Beskrivning

Medical condition Interferes with Patient safety | Medical condition Interferes with Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
6. individual is pregnant, nursing or planning to be pregnant.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
7. individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Beskrivning

Drug use history | Alcoholic Intoxication, Chronic | Adherence Patient instructions Unable | Compliance Study Follow-up Unlikely | Compliance Study Follow-up Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C2239127
UMLS CUI [2]
C0001973
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2051542
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0750558
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C3274571
UMLS CUI [5,3]
C1299582
8. individual is currently enrolled in another investigational drug or device trial.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Hypertension NCT01850901

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure Daytime mean | Blood Pressure Monitoring, Ambulatory | Antihypertensive Agents Quantity | Intolerance to Antihypertensive Agents Quantity | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Calcium Channel Blockers | Adrenergic beta-1 Receptor Antagonists | Diuretics
Item
1. individual has a mean day-time sbp ≥ 135 mmhg, as determined with the use of abpm, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ace/arb, calcium channel blocker, beta blocker, diuretic) and no possibility to take 3 anti-hypertensive drugs.
boolean
C0871470 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0242876 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0003364 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0003015 (UMLS CUI [5])
C0521942 (UMLS CUI [6])
C0006684 (UMLS CUI [7])
C0304516 (UMLS CUI [8])
C0012798 (UMLS CUI [9])
Age
Item
2. individual is ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
1. individual is unable or unwilling to sign informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Cause Secondary to Hypertensive disease
Item
2. individual has a treatable secondary cause of hypertension.
boolean
C0015127 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
GFR estimation by MDRD
Item
3. individual has an egfr below 20 ml/min/1.73m2 using the modification of diet in renal disease (mdrd) calculation.
boolean
C2170215 (UMLS CUI [1])
Renal artery Anatomy Ineligible Treatment
Item
4. individual has renal artery anatomy that is ineligible for treatment
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Medical condition Interferes with Patient safety | Medical condition Interferes with Evaluation
Item
5. individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
6. individual is pregnant, nursing or planning to be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Drug use history | Alcoholic Intoxication, Chronic | Adherence Patient instructions Unable | Compliance Study Follow-up Unlikely | Compliance Study Follow-up Unable
Item
7. individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
boolean
C2239127 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C1510802 (UMLS CUI [3,1])
C2051542 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C1321605 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0750558 (UMLS CUI [4,3])
C1321605 (UMLS CUI [5,1])
C3274571 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
8. individual is currently enrolled in another investigational drug or device trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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