Informações:
Falhas:
ID
39532
Descrição
Sildenafil in HFpEF and PH; ODM derived from: https://clinicaltrials.gov/show/NCT01726049
Link
https://clinicaltrials.gov/show/NCT01726049
Palavras-chave
Versões (1)
- 24/01/2020 24/01/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
24 de janeiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049
Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049
- StudyEvent: Eligibility
Similar models
Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
>18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written inform consent
boolean
C0021430 (UMLS CUI [1])
Pulmonary Hypertension Secondary to Diastolic left ventricular heart failure
Item
ph secondary to diastolic left heart failure defined as
boolean
C0020542 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C4509225 (UMLS CUI [1,3])
C0175668 (UMLS CUI [1,2])
C4509225 (UMLS CUI [1,3])
Pulmonary artery mean pressure
Item
pap mean >25 mmhg
boolean
C0428645 (UMLS CUI [1])
Mean wedge pressure
Item
wedge mean >15 mmhg
boolean
C0456173 (UMLS CUI [1])
Normal left ventricular systolic function Echocardiography | Normal left ventricular systolic function MUGA | Left ventricular ejection fraction
Item
normal systolic lv function on echo/muga (lvef > 45%)
boolean
C3266756 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C3266756 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
C0013516 (UMLS CUI [1,2])
C3266756 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
New York Heart Association Classification | Therapy Heart failure
Item
nyha ii-iv despite hf therapy
boolean
C1275491 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Limitation Severe Exercise | Exception Heart Diseases | Chronic Obstructive Airway Disease
Item
severe noncardiac limitation to exercise (copd etc)
boolean
C0449295 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0024117 (UMLS CUI [3])
C0205082 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0024117 (UMLS CUI [3])
Cause Pulmonary Hypertension | Exception Diastolic Heart Failure
Item
other cause of ph besides diastolic heart failure
boolean
C0015127 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1135196 (UMLS CUI [2,2])
C0020542 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1135196 (UMLS CUI [2,2])
Coronary ischaemia | Recent myocardial infarction
Item
coronary ischemia or recent myocardial infarction (<6 months)
boolean
C0542060 (UMLS CUI [1])
C1998297 (UMLS CUI [2])
C1998297 (UMLS CUI [2])
Hypotension | Blood pressure determination
Item
hypotension ( <90/50 mmhg)
boolean
C0020649 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0005824 (UMLS CUI [2])
Nitrates
Item
ongoing nitrate therapy
boolean
C0028125 (UMLS CUI [1])
CYP3A4 Inhibitors | Ketoconazole | Erythromycin | Cimetidine | Clarithromycin | Itraconazole | voriconazole | Protease Inhibitors | CYP3A4 Inducers | Carbamazepine | Phenytoin | Phenobarbital | Rifampin | ST. JOHN'S WORT EXTRACT | GRAPEFRUIT JUICE
Item
ongoing therapy with cyp3a4 inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or cyp3a4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, sint janskruid ). furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of sildenafil.
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0008783 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0393080 (UMLS CUI [7])
C0033607 (UMLS CUI [8])
C3850041 (UMLS CUI [9])
C0006949 (UMLS CUI [10])
C0031507 (UMLS CUI [11])
C0031412 (UMLS CUI [12])
C0035608 (UMLS CUI [13])
C0813171 (UMLS CUI [14])
C0452456 (UMLS CUI [15])
C0022625 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0008783 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0393080 (UMLS CUI [7])
C0033607 (UMLS CUI [8])
C3850041 (UMLS CUI [9])
C0006949 (UMLS CUI [10])
C0031507 (UMLS CUI [11])
C0031412 (UMLS CUI [12])
C0035608 (UMLS CUI [13])
C0813171 (UMLS CUI [14])
C0452456 (UMLS CUI [15])
Adrenergic alpha-Antagonists
Item
ongoing therapy with alpha -inhibitors
boolean
C0001641 (UMLS CUI [1])
Mitral Valve Dysfunction | Aortic valve Dysfunction
Item
significant mitral or aortic valve dysfunction
boolean
C0026264 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C3887504 (UMLS CUI [1,2])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
Liver Dysfunction Severe
Item
severe liver dysfunction
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Lacking Able to read Dutch Language | Comprehension Dutch Language Unable
Item
unable to read and comprehend dutch language
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376241 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0586740 (UMLS CUI [1,2])
C0376241 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])