ID

37480

Beskrivning

Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01267747

Länk

https://clinicaltrials.gov/show/NCT01267747

Nyckelord

Versioner (1)
  1. 2019-08-01 2019-08-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01267747

Engelsk

Eligibility Atrial Fibrillation NCT01267747

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal evidence (by ecg, holter ecg or medical charts) of aff (paroxysmal, persistent or permanent) in patients with blood pressure > 140/90 mmhg on at least 3 office measurements, or current use of anti-hypertensive drugs;
Beskrivning

Paroxysmal atrial fibrillation ECG | Persistent atrial fibrillation ECG | Permanent atrial fibrillation ECG | Paroxysmal atrial fibrillation Holter Electrocardiography | Persistent atrial fibrillation Holter Electrocardiography | Permanent atrial fibrillation Holter Electrocardiography | Paroxysmal atrial fibrillation Chart | Persistent atrial fibrillation Chart | Permanent atrial fibrillation Chart | Blood pressure determination Quantity | Antihypertensive Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0013798
UMLS CUI [3,1]
C2586056
UMLS CUI [3,2]
C0013798
UMLS CUI [4,1]
C0235480
UMLS CUI [4,2]
C0013801
UMLS CUI [5,1]
C2585653
UMLS CUI [5,2]
C0013801
UMLS CUI [6,1]
C2586056
UMLS CUI [6,2]
C0013801
UMLS CUI [7,1]
C0235480
UMLS CUI [7,2]
C0007963
UMLS CUI [8,1]
C2585653
UMLS CUI [8,2]
C0007963
UMLS CUI [9,1]
C2586056
UMLS CUI [9,2]
C0007963
UMLS CUI [10,1]
C0005824
UMLS CUI [10,2]
C1265611
UMLS CUI [11]
C0003364
written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient refusal to participate to the study;
Beskrivning

Study Subject Participation Status | Refusal to Participate

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1136454
moderate-severe valvular or congenital or myocardial heart disease;
Beskrivning

Heart valve disease Moderate | Heart valve disease Severe | Congenital heart disease | Heart Disease Myocardial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0152021
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1522564
current abnormal thyroid function;
Beskrivning

Thyroid function tests abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0476414
chronic renal failure (screatinine > 200 μm or egfr < 40 ml/min, calculated with mdrd formula);
Beskrivning

Kidney Failure, Chronic | Creatinine measurement, serum | GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2170215
hemochromatosis;
Beskrivning

Hemochromatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0018995
alcohol abuse;
Beskrivning

Alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
acute coronary syndrome, or history of cabg, ptca with/without stenting, acute myocardial infarction;
Beskrivning

Acute Coronary Syndrome | Coronary Artery Bypass Surgery | PTCA With Stenting | PTCA Without Stenting | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C2936173
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C2348535
UMLS CUI [4,1]
C2936173
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C2348535
UMLS CUI [5]
C0027051
hepatitis c virus and/or b and/or hiv infection;
Beskrivning

Hepatitis C | Hepatitis B | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
pheochromocytoma and other known secondary forms of arterial hypertension;
Beskrivning

Pheochromocytoma | Hypertensive disease Secondary

Datatyp

boolean

Alias
UMLS CUI [1]
C0031511
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0175668
hemodynamic instability precluding withdrawal of drugs (e.g. β-blockers, arbs, ace-i, diuretics), interfering with pra (or dra) and aldosterone measurements.
Beskrivning

Hemodynamic instability Excludes Drug withdrawal | Adrenergic beta-1 Receptor Antagonists | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Diuretics | Hemodynamic instability Interferes with Plasma renin measurement | Hemodynamic instability Interferes with Direct renin measurement | Hemodynamic instability Interferes with Aldosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948268
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C2349954
UMLS CUI [2]
C0304516
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0003015
UMLS CUI [5]
C0012798
UMLS CUI [6,1]
C0948268
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2041375
UMLS CUI [7,1]
C0948268
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0373719
UMLS CUI [8,1]
C0948268
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0373535
patients with resistant hypertension in whom antihypertensive drug treatment withdrawal/modifications will be considered unsafe will be investigated on treatment and, if necessary, submitted to avs to exclude a lateralized cause of aldosterone excess. they will be analyzed as a separate group.
Beskrivning

Resistant hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0745130
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Similar models

Eligibility Atrial Fibrillation NCT01267747

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation ECG | Persistent atrial fibrillation ECG | Permanent atrial fibrillation ECG | Paroxysmal atrial fibrillation Holter Electrocardiography | Persistent atrial fibrillation Holter Electrocardiography | Permanent atrial fibrillation Holter Electrocardiography | Paroxysmal atrial fibrillation Chart | Persistent atrial fibrillation Chart | Permanent atrial fibrillation Chart | Blood pressure determination Quantity | Antihypertensive Agents
Item
unequivocal evidence (by ecg, holter ecg or medical charts) of aff (paroxysmal, persistent or permanent) in patients with blood pressure > 140/90 mmhg on at least 3 office measurements, or current use of anti-hypertensive drugs;
boolean
C0235480 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
C2586056 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C0235480 (UMLS CUI [4,1])
C0013801 (UMLS CUI [4,2])
C2585653 (UMLS CUI [5,1])
C0013801 (UMLS CUI [5,2])
C2586056 (UMLS CUI [6,1])
C0013801 (UMLS CUI [6,2])
C0235480 (UMLS CUI [7,1])
C0007963 (UMLS CUI [7,2])
C2585653 (UMLS CUI [8,1])
C0007963 (UMLS CUI [8,2])
C2586056 (UMLS CUI [9,1])
C0007963 (UMLS CUI [9,2])
C0005824 (UMLS CUI [10,1])
C1265611 (UMLS CUI [10,2])
C0003364 (UMLS CUI [11])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Refusal to Participate
Item
patient refusal to participate to the study;
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2])
Heart valve disease Moderate | Heart valve disease Severe | Congenital heart disease | Heart Disease Myocardial
Item
moderate-severe valvular or congenital or myocardial heart disease;
boolean
C0018824 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018824 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0152021 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1522564 (UMLS CUI [4,2])
Thyroid function tests abnormal
Item
current abnormal thyroid function;
boolean
C0476414 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine measurement, serum | GFR estimation by MDRD
Item
chronic renal failure (screatinine > 200 μm or egfr < 40 ml/min, calculated with mdrd formula);
boolean
C0022661 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2170215 (UMLS CUI [3])
Hemochromatosis
Item
hemochromatosis;
boolean
C0018995 (UMLS CUI [1])
Alcohol abuse
Item
alcohol abuse;
boolean
C0085762 (UMLS CUI [1])
Acute Coronary Syndrome | Coronary Artery Bypass Surgery | PTCA With Stenting | PTCA Without Stenting | Myocardial Infarction
Item
acute coronary syndrome, or history of cabg, ptca with/without stenting, acute myocardial infarction;
boolean
C0948089 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C2936173 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C2348535 (UMLS CUI [3,3])
C2936173 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C2348535 (UMLS CUI [4,3])
C0027051 (UMLS CUI [5])
Hepatitis C | Hepatitis B | HIV Infection
Item
hepatitis c virus and/or b and/or hiv infection;
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Pheochromocytoma | Hypertensive disease Secondary
Item
pheochromocytoma and other known secondary forms of arterial hypertension;
boolean
C0031511 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
Hemodynamic instability Excludes Drug withdrawal | Adrenergic beta-1 Receptor Antagonists | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Diuretics | Hemodynamic instability Interferes with Plasma renin measurement | Hemodynamic instability Interferes with Direct renin measurement | Hemodynamic instability Interferes with Aldosterone measurement
Item
hemodynamic instability precluding withdrawal of drugs (e.g. β-blockers, arbs, ace-i, diuretics), interfering with pra (or dra) and aldosterone measurements.
boolean
C0948268 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
C0304516 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0003015 (UMLS CUI [4])
C0012798 (UMLS CUI [5])
C0948268 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2041375 (UMLS CUI [6,3])
C0948268 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0373719 (UMLS CUI [7,3])
C0948268 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0373535 (UMLS CUI [8,3])
Resistant hypertension
Item
patients with resistant hypertension in whom antihypertensive drug treatment withdrawal/modifications will be considered unsafe will be investigated on treatment and, if necessary, submitted to avs to exclude a lateralized cause of aldosterone excess. they will be analyzed as a separate group.
boolean
C0745130 (UMLS CUI [1])
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