ID

15989

Description

Lifestyle Interventions in Treatment-Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02342808

Link

https://clinicaltrials.gov/show/NCT02342808

Keywords

Versions (1)
  1. 6/24/16 6/24/16 -
Uploaded on

June 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Treatment-Resistant Hypertension NCT02342808

English

Eligibility Treatment-Resistant Hypertension NCT02342808

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of resistant hypertension (rh) within the last 6 months. in the absence of a specific rh diagnosis, individuals being treated for two or more weeks with at least 3 antihypertensive medications of different classes, including a diuretic, with clinic sbp ≥ 140 mm hg or dbp ≥ 90 mm hg, will be eligible. individuals being treated with 4 or more anti-hypertensive medications (including a diuretic) with sbp
Description

HYPERTENSION RESISTANT Therapeutic procedure Antihypertensive Agents Diuretics | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0745130
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0003364
UMLS CUI [1,4]
C0012798
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
≥ 130 or dbp ≥ 85 mm hg will also be eligible.
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
adherent to prescribed medications
Description

Prescription of drug adherent

Data type

boolean

Alias
UMLS CUI [1,1]
C2239117
UMLS CUI [1,2]
C0334154
overweight (bmi > 25 kg/m2 with max weight of 300 lbs)
Description

Body mass index 25-29 - overweight

Data type

boolean

Alias
UMLS CUI [1]
C0424672
sedentary
Description

Sedentary

Data type

boolean

Alias
UMLS CUI [1]
C0205254
willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
Description

Randomization Willing | participation Surgical and medical procedures Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1948041
UMLS CUI [2,3]
C0085732
informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary htn, non-adherence to anti-htn medications
Description

Secondary hypertension | Antihypertensive Agents Medication Nonadherence

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0746935
severe ckd (egfr <45 ml/min/1.73m2)
Description

Chronic kidney disease, stage 4 (severe)

Data type

boolean

Alias
UMLS CUI [1]
C1561641
severe ischemic heart disease (ccs class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on treadmill testing)
Description

Myocardial Ischemia Severe | Canadian Cardiovascular Society classification of angina | Treadmill Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1277207
UMLS CUI [3]
C0087110
severe heart failure (nyha association class 3 or 4), high grade arrhythmias, severe valvular heart disease
Description

Heart failure; Severe | New York Heart Association Classification | Cardiac Arrhythmia high grade | Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1275491
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018824
UMLS CUI [4,2]
C0205082
severe asthma or chronic obstructive lung disease
Description

Severe asthma | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0024117
diabetes requiring insulin
Description

DIABETES MELLITUS NOS INSULIN REQUIRING

Data type

boolean

Alias
UMLS CUI [1]
C0743124
musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
Description

musculoskeletal problem Preventing participation Exercise, Aerobic | Nervous system problem Preventing participation Exercise, Aerobic

Data type

boolean

Alias
UMLS CUI [1,1]
C0026859
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0001701
UMLS CUI [2,1]
C0221571
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0001701
major psychiatric disorder, a history of drug abuse, alcohol consumption >14 drinks/week
Description

Mental disorders Major | Drug abuse | Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0001948
life-limiting comorbid medical condition such as cancer
Description

Comorbidity Lifetime Limiting | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C4071830
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0006826
prior gastric bypass surgery
Description

Gastric Bypass Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0017125
UMLS CUI [1,2]
C0543467
currently pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
cognitively impaired
Description

Impaired cognition

Data type

boolean

Alias
UMLS CUI [1]
C0338656
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Similar models

Eligibility Treatment-Resistant Hypertension NCT02342808

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HYPERTENSION RESISTANT Therapeutic procedure Antihypertensive Agents Diuretics | Systolic Pressure | Diastolic blood pressure
Item
diagnosis of resistant hypertension (rh) within the last 6 months. in the absence of a specific rh diagnosis, individuals being treated for two or more weeks with at least 3 antihypertensive medications of different classes, including a diuretic, with clinic sbp ≥ 140 mm hg or dbp ≥ 90 mm hg, will be eligible. individuals being treated with 4 or more anti-hypertensive medications (including a diuretic) with sbp
boolean
C0745130 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
C0012798 (UMLS CUI [1,4])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Systolic Pressure
Item
≥ 130 or dbp ≥ 85 mm hg will also be eligible.
boolean
C0871470 (UMLS CUI [1])
Prescription of drug adherent
Item
adherent to prescribed medications
boolean
C2239117 (UMLS CUI [1,1])
C0334154 (UMLS CUI [1,2])
Body mass index 25-29 - overweight
Item
overweight (bmi > 25 kg/m2 with max weight of 300 lbs)
boolean
C0424672 (UMLS CUI [1])
Sedentary
Item
sedentary
boolean
C0205254 (UMLS CUI [1])
Randomization Willing | participation Surgical and medical procedures Ability
Item
willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
boolean
C0034656 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C1948041 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Antihypertensive Agents Medication Nonadherence
Item
secondary htn, non-adherence to anti-htn medications
boolean
C0155616 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C0746935 (UMLS CUI [2,2])
Chronic kidney disease, stage 4 (severe)
Item
severe ckd (egfr <45 ml/min/1.73m2)
boolean
C1561641 (UMLS CUI [1])
Myocardial Ischemia Severe | Canadian Cardiovascular Society classification of angina | Treadmill Test
Item
severe ischemic heart disease (ccs class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on treadmill testing)
boolean
C0151744 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1277207 (UMLS CUI [2])
C0087110 (UMLS CUI [3])
Heart failure; Severe | New York Heart Association Classification | Cardiac Arrhythmia high grade | Heart valve disease Severe
Item
severe heart failure (nyha association class 3 or 4), high grade arrhythmias, severe valvular heart disease
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018824 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Severe asthma | Chronic Obstructive Airway Disease
Item
severe asthma or chronic obstructive lung disease
boolean
C0581126 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
DIABETES MELLITUS NOS INSULIN REQUIRING
Item
diabetes requiring insulin
boolean
C0743124 (UMLS CUI [1])
musculoskeletal problem Preventing participation Exercise, Aerobic | Nervous system problem Preventing participation Exercise, Aerobic
Item
musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
boolean
C0026859 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0001701 (UMLS CUI [1,4])
C0221571 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0001701 (UMLS CUI [2,4])
Mental disorders Major | Drug abuse | Alcohol consumption
Item
major psychiatric disorder, a history of drug abuse, alcohol consumption >14 drinks/week
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0013146 (UMLS CUI [2])
C0001948 (UMLS CUI [3])
Comorbidity Lifetime Limiting | Malignant Neoplasms
Item
life-limiting comorbid medical condition such as cancer
boolean
C0009488 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Gastric Bypass Operative Surgical Procedures
Item
prior gastric bypass surgery
boolean
C0017125 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Pregnancy
Item
currently pregnant
boolean
C0032961 (UMLS CUI [1])
Impaired cognition
Item
cognitively impaired
boolean
C0338656 (UMLS CUI [1])
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