Antihypertensive Agents prescribed unchanged
Item
no change in prescribed antihypertension medications within the previous 30 days
boolean
C0003364 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Brachial artery Diameter Vascular Ultrasound High resolution | Requirement Flow-Mediated Vasodilation Measurement
Item
study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for fmd measurements
boolean
C0006087 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0948543 (UMLS CUI [1,3])
C1719039 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C4085863 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Sitting blood pressure mean | Systolic Pressure | Diastolic blood pressure
Item
ish with the following mean seated bp: sbp > 145 and < 180 mmhg. diastolic blood pressure < 90mmhg
boolean
C0580946 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypersensitivity Sapropterin | Hypersensitivity Sapropterin Excipient
Item
has known hypersensitivity to 6rbh4 or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0048897 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0048897 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding at screening
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Investigational Medical Device
Item
use of any investigational product or investigational medical device within 30 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Safety | Condition Interferes with Safety | Heart failure | Atrial Fibrillation | Aortic valve disorder | Blood Coagulation Disorders | Syncope Repeated | Vertigo Repeated | Gastroesophageal reflux disease Severe | Gastrointestinal ulcer | Vascular Disease Coronary Symptomatic | Peripheral Vascular Disease Symptomatic | Cardiac Arrhythmia | Nervous system disorder Serious | Seizures | Organ Transplantation | Organ failure
Item
current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe gerd, gi ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
C0018801 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C1260873 (UMLS CUI [7])
C0005779 (UMLS CUI [8])
C0039070 (UMLS CUI [9,1])
C0205341 (UMLS CUI [9,2])
C0042571 (UMLS CUI [10,1])
C0205341 (UMLS CUI [10,2])
C0017168 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0237938 (UMLS CUI [12])
C0042373 (UMLS CUI [13,1])
C1522318 (UMLS CUI [13,2])
C0231220 (UMLS CUI [13,3])
C0085096 (UMLS CUI [14,1])
C0231220 (UMLS CUI [14,2])
C0003811 (UMLS CUI [15])
C0027765 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
C0036572 (UMLS CUI [17])
C0029216 (UMLS CUI [18])
C0349410 (UMLS CUI [19])
Secondary hypertension | Other medical condition
Item
hypertension secondary to other medical conditions
boolean
C0155616 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
Comorbidity Severe | Life Expectancy Limited
Item
any severe comorbid condition that would limit life expectancy to <6 months
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Substance Containing Nicotine
Item
current use of any nicotine containing substances
boolean
C0439861 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Operative Surgical Procedures
Item
mi, stroke or surgery within 90 days before screening visit
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Coronary Artery Bypass Surgery
Item
cabg within 6 months before the screening visit
boolean
C0010055 (UMLS CUI [1])
Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased | GGT elevated
Item
serum creatinine >2.0mg/dl or ast, alt, ggt levels >2times upper limit of normal
boolean
C0201976 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0239702 (UMLS CUI [4])
Pharmaceutical Preparations Preventing Folic acid metabolism | Phosphodiesterase 5 inhibitor | Phosphodiesterase 3 Inhibitors
Item
concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
boolean
C0013227 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1157079 (UMLS CUI [1,3])
C1318700 (UMLS CUI [2])
C2267032 (UMLS CUI [3])
Sapropterin
Item
previous treatment with any formulation of bh4
boolean
C0048897 (UMLS CUI [1])