ID

37480

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01267747

Trefwoorden

  1. 01-08-19 01-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 augustus 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT01267747

Eligibility Atrial Fibrillation NCT01267747

Inclusion Criteria
Beschrijving

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;
Beschrijving

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

Datatype

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.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Study Subject Participation Status | Refusal to Participate

Datatype

boolean

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

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

Datatype

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;
Beschrijving

Thyroid function tests abnormal

Datatype

boolean

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

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

Datatype

boolean

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

Hemochromatosis

Datatype

boolean

Alias
UMLS CUI [1]
C0018995
alcohol abuse;
Beschrijving

Alcohol abuse

Datatype

boolean

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

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

Datatype

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;
Beschrijving

Hepatitis C | Hepatitis B | HIV Infection

Datatype

boolean

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

Pheochromocytoma | Hypertensive disease Secondary

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Resistant hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0745130

Similar models

Eligibility Atrial Fibrillation NCT01267747

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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