ID

31725

Description

Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA); ODM derived from: https://clinicaltrials.gov/show/NCT01181284

Link

https://clinicaltrials.gov/show/NCT01181284

Keywords

Versions (1)
  1. 9/23/18 9/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT01181284

English

Eligibility Pulmonary Arterial Hypertension NCT01181284

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
world health organization (who) group i pah with prior documentation of peripheral vascular resistance (pvr) > 3 wu and wedge(pcw) 16 or less.
Description

Pulmonary arterial hypertension WHO classification | Peripheral Vascular Resistance Wood units Quantity | Pulmonary Capillary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C1258192
UMLS CUI [2,2]
C0439525
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0086879
who functional class i-iii
Description

WHO classification

Data type

boolean

Alias
UMLS CUI [1]
C4267671
6 minute walk distance 150-575 meters
Description

6-Minute Walk Test Meter Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
women of child bearing potential must have a negative pregnancy test and be using effective contraception
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
receiving therapy with phosphodiesterase-5 inhibitor for pah (sildenafil or tadalafil) for at least 3 months and with stable dose for at least 30 days
Description

Phosphodiesterase 5 inhibitor Dose Stable Pulmonary arterial hypertension | sildenafil | tadalafil

Data type

boolean

Alias
UMLS CUI [1,1]
C1318700
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C2973725
UMLS CUI [2]
C0529793
UMLS CUI [3]
C1176316
if already receiving therapy with endothelin receptor antagonists must have been on therapy for at least 3 months and on stable dose for at least 30 days
Description

Endothelin receptor antagonist Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1134681
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy or intolerance to captopril or other angiotensin converting enzyme inhibitors
Description

Captopril allergy | Intolerance to Captopril | Angiotensin-converting-enzyme inhibitor allergy | Intolerance to Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0571940
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0006938
UMLS CUI [3]
C0571939
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003015
systemic systolic blood pressure less than 100 mm hg
Description

Systolic Pressure Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205373
therapy with prostanoids (iloprost, treprostinil, epoprostenol) within preceding 3 months
Description

Prostaglandins | Iloprost | Treprostinil | Epoprostenol

Data type

boolean

Alias
UMLS CUI [1]
C0033554
UMLS CUI [2]
C0079594
UMLS CUI [3]
C1145760
UMLS CUI [4]
C0033567
pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
creatinine > 2.0 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
potassium > 5.0 meq/dl
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
unable to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
tlc or vc <60% predicted
Description

Percent Predicted Total Lung Capacity | Percentage of predicted vital capacity

Data type

boolean

Alias
UMLS CUI [1]
C3828589
UMLS CUI [2]
C2919340
untreated obstructive sleep apnea
Description

Obstructive Sleep Apnea untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0520679
UMLS CUI [1,2]
C0332155
lvef < 40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
hb < 10 mg/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT01181284

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
Pulmonary arterial hypertension WHO classification | Peripheral Vascular Resistance Wood units Quantity | Pulmonary Capillary Wedge Pressure
Item
world health organization (who) group i pah with prior documentation of peripheral vascular resistance (pvr) > 3 wu and wedge(pcw) 16 or less.
boolean
C2973725 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C1258192 (UMLS CUI [2,1])
C0439525 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0086879 (UMLS CUI [3])
WHO classification
Item
who functional class i-iii
boolean
C4267671 (UMLS CUI [1])
6-Minute Walk Test Meter Quantity
Item
6 minute walk distance 150-575 meters
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of child bearing potential must have a negative pregnancy test and be using effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Phosphodiesterase 5 inhibitor Dose Stable Pulmonary arterial hypertension | sildenafil | tadalafil
Item
receiving therapy with phosphodiesterase-5 inhibitor for pah (sildenafil or tadalafil) for at least 3 months and with stable dose for at least 30 days
boolean
C1318700 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C2973725 (UMLS CUI [1,4])
C0529793 (UMLS CUI [2])
C1176316 (UMLS CUI [3])
Endothelin receptor antagonist Dose Stable
Item
if already receiving therapy with endothelin receptor antagonists must have been on therapy for at least 3 months and on stable dose for at least 30 days
boolean
C1134681 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Captopril allergy | Intolerance to Captopril | Angiotensin-converting-enzyme inhibitor allergy | Intolerance to Angiotensin-Converting Enzyme Inhibitors
Item
allergy or intolerance to captopril or other angiotensin converting enzyme inhibitors
boolean
C0571940 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0006938 (UMLS CUI [2,2])
C0571939 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0003015 (UMLS CUI [4,2])
Systolic Pressure Systemic
Item
systemic systolic blood pressure less than 100 mm hg
boolean
C0871470 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Prostaglandins | Iloprost | Treprostinil | Epoprostenol
Item
therapy with prostanoids (iloprost, treprostinil, epoprostenol) within preceding 3 months
boolean
C0033554 (UMLS CUI [1])
C0079594 (UMLS CUI [2])
C1145760 (UMLS CUI [3])
C0033567 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum potassium measurement
Item
potassium > 5.0 meq/dl
boolean
C0302353 (UMLS CUI [1])
Informed Consent Unable
Item
unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Percent Predicted Total Lung Capacity | Percentage of predicted vital capacity
Item
tlc or vc <60% predicted
boolean
C3828589 (UMLS CUI [1])
C2919340 (UMLS CUI [2])
Obstructive Sleep Apnea untreated
Item
untreated obstructive sleep apnea
boolean
C0520679 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef < 40%
boolean
C0428772 (UMLS CUI [1])
Hemoglobin measurement
Item
hb < 10 mg/dl
boolean
C0518015 (UMLS CUI [1])
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