ID

39045

Description

Ranolazine in Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01163734

Link

https://clinicaltrials.gov/show/NCT01163734

Keywords

Versions (2)
  1. 11/23/19 11/23/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diastolic Heart Failure NCT01163734

English

Eligibility Diastolic Heart Failure NCT01163734

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females aged > 40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. clinical symptoms of heart failure (nyha class ii-iii) at time of screening (e.g., dyspnea, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema)
Description

Symptoms Heart failure New York Heart Association Classification | Dyspnea | Paroxysmal nocturnal dyspnea | Orthopnea | Edema of lower extremity Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0013404
UMLS CUI [3]
C1956415
UMLS CUI [4]
C0085619
UMLS CUI [5,1]
C0239340
UMLS CUI [5,2]
C0238767
3. left ventricular ejection fraction (lvef) > 45% at screening
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
4. with:
Description

with

Data type

boolean

Alias
UMLS CUI [1]
C0332287
e/e' > 15 measured by tissue doppler echocardiography at screening
Description

US.tissue doppler Mitral E/e' Ratio Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C4072647
UMLS CUI [1,2]
C4288734
UMLS CUI [1,3]
C0013516
nt-pro-bnp > 220pg/ml at screening
Description

N terminal pro-brain natriuretic peptide level

Data type

boolean

Alias
UMLS CUI [1]
C1533071
average resting lvedp >18 mm hg (refer to continued eligibility criteria),
Description

Average Left ventricular end-diastolic pressure level Resting

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0456190
UMLS CUI [1,3]
C0035253
average resting time constant of relaxation (tau) > 50 ms at time of cardiac catheterization (refer to continued eligibility criteria)
Description

Average Resting Time Constant Relaxation | Cardiac Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0035253
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1881607
UMLS CUI [1,5]
C0035028
UMLS CUI [2]
C0018795
5. signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute cardiac decompensation requiring mechanical ventilation
Description

Heart Decompensation Requirement Mechanical ventilation

Data type

boolean

Alias
UMLS CUI [1,1]
C1961112
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0199470
2. hypotension with blood pressure < 90/50 mm hg
Description

Hypotension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0005824
3. primary hypertrophic or restrictive cardiomyopathy or systemic illness associated with infiltrative heart disease (e.g., cardiac amyloidosis)
Description

Primary idiopathic hypertrophic cardiomyopathy | Primary idiopathic restrictive cardiomyopathy | Systemic disease Associated with Heart Disease Infiltrating | Amyloidosis; heart

Data type

boolean

Alias
UMLS CUI [1]
C0264847
UMLS CUI [2]
C0264833
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0018799
UMLS CUI [3,4]
C0332448
UMLS CUI [4]
C1387310
4. pericardial constriction
Description

Pericardial constriction

Data type

boolean

Alias
UMLS CUI [1]
C0240709
5. hemodynamically significant uncorrected obstructive or regurgitant valvular disease
Description

Valvular disease Obstructive uncorrected | Valvular regurgitation uncorrected

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C4072785
UMLS CUI [2,1]
C0042300
UMLS CUI [2,2]
C4072785
6. cor pulmonale or other causes of right heart failure not associated with left ventricular dysfunction
Description

Cor pulmonale | Etiology Right Heart Failure | Relationship Absent Left Ventricular Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0034072
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0235527
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0242698
7. clinically significant pulmonary disease in the opinion of the investigator or requiring home oxygen or oral steroid therapy
Description

Lung disease | Requirement Home oxygen therapy | Requirement Oral steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1960973
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0574135
8. history of serious cardiac dysrrhythmias including atrial fibrillation with resting heart rate of > 100 beats per minute
Description

Cardiac Arrhythmia Serious | Atrial Fibrillation | RESTING HEART RATE beats per minute

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0004238
UMLS CUI [3,1]
C1821417
UMLS CUI [3,2]
C0439385
9. need for treatment with class i or iii antiarrhythmic medications
Description

Patient need for Anti-Arrhythmia Agents Class

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003195
UMLS CUI [1,3]
C0456387
10. implantable pacemaker, cardioverter-defibrillator, or left ventricular assist device
Description

Artificial cardiac pacemaker | Implantable defibrillator | Left ventricular assist device

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C0181598
11. clinically significant chronic hepatic impairment (child-pugh class b [moderate] or class c [severe])
Description

Hepatic impairment Moderate chronic Child-Pugh Classification | Hepatic impairment Severe chronic Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C2347612
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205191
UMLS CUI [2,4]
C2347612
12. severe renal insufficiency defined as creatinine clearance ≤30 ml/min as calculated by cockcroft-gault formula or modified diet in renal disease (mdrd) equation.
Description

Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance Modification of diet in renal disease formula

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
UMLS CUI [3,1]
C0812399
UMLS CUI [3,2]
C3839656
13. history of congenital or a family history of long qt syndrome, or known acquired qt interval prolongation
Description

Congenital long QT syndrome | Family history of long QT syndrome | Acquired long QT syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2]
C3839836
UMLS CUI [3]
C2732979
14. inability to exercise due to other co-morbidities that may affect performance of cardiopulmonary exercise test (cpet) (e.g., osteoarthritis, peripheral vascular disease)
Description

Exercise Unable | Comorbidity Affecting Cardiopulmonary Exercise Test | Osteoarthritis | Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2959886
UMLS CUI [3]
C0029408
UMLS CUI [4]
C0085096
15. current treatment with potent and moderate cyp3a inhibitors
Description

CYP3A Inhibitors Strong | CYP3A Inhibitors Moderate

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850056
UMLS CUI [2,2]
C0205081
16. current treatment with potent cyp3a inducers (e.g., rifampin/rifampicin, st. john's wort, carbamazepin/carbamazepine)
Description

CYP3A Inducers Strong | Rifampin | ST. JOHN'S WORT EXTRACT | Carbamazepine

Data type

boolean

Alias
UMLS CUI [1,1]
C3850044
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0035608
UMLS CUI [3]
C0813171
UMLS CUI [4]
C0006949
17. prior treatment with ranolazine
Description

ranolazine

Data type

boolean

Alias
UMLS CUI [1]
C0073633
18. other conditions that in the opinion of the investigator may increase the risk to the patient (e.g. pts with weight ≤60 kg), prevent compliance with study protocol or compromise the quality of the clinical trial
Description

Condition At risk Patient | Body Weight | Condition Preventing Protocol Compliance | Condition compromises Quality Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2]
C0005910
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0332306
UMLS CUI [4,4]
C0008976
continued eligibility criteria:
Description

Eligibility Criteria Continued

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0549178
patients must continue to meet eligibility criteria and have an average (of 3 measurements) resting lvedp > 18 mm hg and resting tau > 50 ms at time of cardiac catheterization to receive study drug.
Description

Eligibility Criteria Fulfill Continuous | Average Left ventricular end-diastolic pressure level Resting | Resting tau | Cardiac Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0549178
UMLS CUI [2,1]
C1510992
UMLS CUI [2,2]
C0456190
UMLS CUI [2,3]
C0035253
UMLS CUI [3,1]
C0035253
UMLS CUI [3,2]
C1720655
UMLS CUI [4]
C0018795
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Similar models

Eligibility Diastolic Heart Failure NCT01163734

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females aged > 40 years
boolean
C0001779 (UMLS CUI [1])
Symptoms Heart failure New York Heart Association Classification | Dyspnea | Paroxysmal nocturnal dyspnea | Orthopnea | Edema of lower extremity Bilateral
Item
2. clinical symptoms of heart failure (nyha class ii-iii) at time of screening (e.g., dyspnea, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema)
boolean
C1457887 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2])
C1956415 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C0239340 (UMLS CUI [5,1])
C0238767 (UMLS CUI [5,2])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction (lvef) > 45% at screening
boolean
C0428772 (UMLS CUI [1])
with
Item
4. with:
boolean
C0332287 (UMLS CUI [1])
US.tissue doppler Mitral E/e' Ratio Echocardiography
Item
e/e' > 15 measured by tissue doppler echocardiography at screening
boolean
C4072647 (UMLS CUI [1,1])
C4288734 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
N terminal pro-brain natriuretic peptide level
Item
nt-pro-bnp > 220pg/ml at screening
boolean
C1533071 (UMLS CUI [1])
Average Left ventricular end-diastolic pressure level Resting
Item
average resting lvedp >18 mm hg (refer to continued eligibility criteria),
boolean
C1510992 (UMLS CUI [1,1])
C0456190 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
Average Resting Time Constant Relaxation | Cardiac Catheterization
Item
average resting time constant of relaxation (tau) > 50 ms at time of cardiac catheterization (refer to continued eligibility criteria)
boolean
C1510992 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1881607 (UMLS CUI [1,4])
C0035028 (UMLS CUI [1,5])
C0018795 (UMLS CUI [2])
Informed Consent
Item
5. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Decompensation Requirement Mechanical ventilation
Item
1. acute cardiac decompensation requiring mechanical ventilation
boolean
C1961112 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0199470 (UMLS CUI [1,3])
Hypotension | Blood pressure determination
Item
2. hypotension with blood pressure < 90/50 mm hg
boolean
C0020649 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Primary idiopathic hypertrophic cardiomyopathy | Primary idiopathic restrictive cardiomyopathy | Systemic disease Associated with Heart Disease Infiltrating | Amyloidosis; heart
Item
3. primary hypertrophic or restrictive cardiomyopathy or systemic illness associated with infiltrative heart disease (e.g., cardiac amyloidosis)
boolean
C0264847 (UMLS CUI [1])
C0264833 (UMLS CUI [2])
C0442893 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0332448 (UMLS CUI [3,4])
C1387310 (UMLS CUI [4])
Pericardial constriction
Item
4. pericardial constriction
boolean
C0240709 (UMLS CUI [1])
Valvular disease Obstructive uncorrected | Valvular regurgitation uncorrected
Item
5. hemodynamically significant uncorrected obstructive or regurgitant valvular disease
boolean
C3258293 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
C0042300 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
Cor pulmonale | Etiology Right Heart Failure | Relationship Absent Left Ventricular Dysfunction
Item
6. cor pulmonale or other causes of right heart failure not associated with left ventricular dysfunction
boolean
C0034072 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0235527 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0242698 (UMLS CUI [3,3])
Lung disease | Requirement Home oxygen therapy | Requirement Oral steroid therapy
Item
7. clinically significant pulmonary disease in the opinion of the investigator or requiring home oxygen or oral steroid therapy
boolean
C0024115 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C1960973 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0574135 (UMLS CUI [3,2])
Cardiac Arrhythmia Serious | Atrial Fibrillation | RESTING HEART RATE beats per minute
Item
8. history of serious cardiac dysrrhythmias including atrial fibrillation with resting heart rate of > 100 beats per minute
boolean
C0003811 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C1821417 (UMLS CUI [3,1])
C0439385 (UMLS CUI [3,2])
Patient need for Anti-Arrhythmia Agents Class
Item
9. need for treatment with class i or iii antiarrhythmic medications
boolean
C0686904 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Artificial cardiac pacemaker | Implantable defibrillator | Left ventricular assist device
Item
10. implantable pacemaker, cardioverter-defibrillator, or left ventricular assist device
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C0181598 (UMLS CUI [3])
Hepatic impairment Moderate chronic Child-Pugh Classification | Hepatic impairment Severe chronic Child-Pugh Classification
Item
11. clinically significant chronic hepatic impairment (child-pugh class b [moderate] or class c [severe])
boolean
C0948807 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C2347612 (UMLS CUI [1,4])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C2347612 (UMLS CUI [2,4])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance Modification of diet in renal disease formula
Item
12. severe renal insufficiency defined as creatinine clearance ≤30 ml/min as calculated by cockcroft-gault formula or modified diet in renal disease (mdrd) equation.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
C0812399 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
Congenital long QT syndrome | Family history of long QT syndrome | Acquired long QT syndrome
Item
13. history of congenital or a family history of long qt syndrome, or known acquired qt interval prolongation
boolean
C1141890 (UMLS CUI [1])
C3839836 (UMLS CUI [2])
C2732979 (UMLS CUI [3])
Exercise Unable | Comorbidity Affecting Cardiopulmonary Exercise Test | Osteoarthritis | Peripheral Vascular Disease
Item
14. inability to exercise due to other co-morbidities that may affect performance of cardiopulmonary exercise test (cpet) (e.g., osteoarthritis, peripheral vascular disease)
boolean
C0015259 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2959886 (UMLS CUI [2,3])
C0029408 (UMLS CUI [3])
C0085096 (UMLS CUI [4])
CYP3A Inhibitors Strong | CYP3A Inhibitors Moderate
Item
15. current treatment with potent and moderate cyp3a inhibitors
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
CYP3A Inducers Strong | Rifampin | ST. JOHN'S WORT EXTRACT | Carbamazepine
Item
16. current treatment with potent cyp3a inducers (e.g., rifampin/rifampicin, st. john's wort, carbamazepin/carbamazepine)
boolean
C3850044 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0035608 (UMLS CUI [2])
C0813171 (UMLS CUI [3])
C0006949 (UMLS CUI [4])
ranolazine
Item
17. prior treatment with ranolazine
boolean
C0073633 (UMLS CUI [1])
Condition At risk Patient | Body Weight | Condition Preventing Protocol Compliance | Condition compromises Quality Clinical Trial
Item
18. other conditions that in the opinion of the investigator may increase the risk to the patient (e.g. pts with weight ≤60 kg), prevent compliance with study protocol or compromise the quality of the clinical trial
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0005910 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0332306 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
Eligibility Criteria Continued
Item
continued eligibility criteria:
boolean
C1516637 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Eligibility Criteria Fulfill Continuous | Average Left ventricular end-diastolic pressure level Resting | Resting tau | Cardiac Catheterization
Item
patients must continue to meet eligibility criteria and have an average (of 3 measurements) resting lvedp > 18 mm hg and resting tau > 50 ms at time of cardiac catheterization to receive study drug.
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1510992 (UMLS CUI [2,1])
C0456190 (UMLS CUI [2,2])
C0035253 (UMLS CUI [2,3])
C0035253 (UMLS CUI [3,1])
C1720655 (UMLS CUI [3,2])
C0018795 (UMLS CUI [4])
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