ID

23902

Beschreibung

Interventricular Delay of Lumax HF-T for Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00508391

Link

https://clinicaltrials.gov/show/NCT00508391

Stichworte

Versionen (1)
  1. 17.07.17 17.07.17 -
Hochgeladen am

17. Juli 2017

DOI

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Eligibility Congestive Heart Failure NCT00508391

Englisch

Eligibility Congestive Heart Failure NCT00508391

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the indications for therapy
Beschreibung

Therapeutic procedure Indication Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1550543
successfully implanted with a biotronik lumax hf-t crt-d system and have received sim for a minimum of 30 days prior to enrollment. a successful implantation is defined as having a measured lv pacing threshold which allows for a minimum 1-volt safety margin without any phrenic nerve stimulation at the time of enrollment.
Beschreibung

Heart implantation | Left ventricle Pacing Threshold | Margin of safety Volt Quantity | Phrenic Nerve Stimulation Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1293382
UMLS CUI [2,1]
C0225897
UMLS CUI [2,2]
C0199640
UMLS CUI [2,3]
C0449864
UMLS CUI [3,1]
C0243168
UMLS CUI [3,2]
C0439502
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1737692
UMLS CUI [4,2]
C0332197
treated with stable and optimal chf medications, which includes an ace inhibitor (ace-i) or angiotensin receptor blocker (arb) at therapeutic dose for 1 month prior to enrollment, if tolerated, and a beta blocker that is approved and indicated for hf for 3 months prior to enrollment, if tolerated, with a stable dosage for 1 month prior to enrollment. if the patient is intolerant of ace-i or beta blockers, documented evidence must be available. eplerenone requires dosage stability for 1 month prior to enrollment. diuretics may be used as necessary to keep the patient euvolemic. therapeutic equivalence for ace-i substitutions is allowed within the enrollment stability timeliness. stable is defined as no more than a 100% increase or a 50% decrease in dose.
Beschreibung

Pharmaceutical Preparations Stable Congestive heart failure | Angiotensin-Converting Enzyme Inhibitors Dosage Therapeutic | Angiotensin II receptor antagonist Dosage Therapeutic | Adrenergic beta-Antagonists Dosage Stable | Indication for Heart failure | Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Adrenergic beta-Antagonists | Eplerenone Dosage Stable | Diuretics | Euvolemia | Angiotensin-Converting Enzyme Inhibitors Substitution Dosage Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018802
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0302350
UMLS CUI [3,1]
C0521942
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0302350
UMLS CUI [4,1]
C0001645
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0392360
UMLS CUI [5,2]
C0018801
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0003015
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0001645
UMLS CUI [8,1]
C0961485
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205360
UMLS CUI [9]
C0012798
UMLS CUI [10]
C1845208
UMLS CUI [11,1]
C0003015
UMLS CUI [11,2]
C2936279
UMLS CUI [11,3]
C0178602
UMLS CUI [11,4]
C0205360
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
able to understand the nature of the study and give informed consent
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
able to complete all testing required by the clinical protocol, including the 6-minute walk test and qol questionnaire
Beschreibung

Testing Completion | 6-minute walk test Completion | Quality of life Questionnaire Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0518214
UMLS CUI [3,2]
C0034394
UMLS CUI [3,3]
C0205197
available for follow-up visits on a regular basis at the investigational site
Beschreibung

Availability Follow-up visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0589121
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
meet one or more of the contraindications
Beschreibung

Medical contraindication Quantity Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
have a life expectancy of less than 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
expected to receive heart transplantation within 6 months
Beschreibung

Heart Transplantation Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
have had more than 1 chf-related hospitalization within past 30 days
Beschreibung

Hospitalization Quantity Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0018802
currently receiving iv inotropic medications
Beschreibung

Inotropic agent Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
chronic atrial fibrillation
Beschreibung

Chronic atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0694539
enrolled in another cardiovascular or pharmacological clinical investigation, except for fda required post-market registries
Beschreibung

Study Subject Participation Status | Scientific investigation Cardiovascular | Pharmacological study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0683933
UMLS CUI [2,2]
C3887460
UMLS CUI [3]
C1831759
any condition preventing the patient from being able to perform required testing
Beschreibung

Condition Preventing Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0039593
presence of another life-threatening, underlying illness separate from their cardiac disorder
Beschreibung

Comorbidity Life Threatening | Heart Disease Separated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443299
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Ähnliche Modelle

Eligibility Congestive Heart Failure NCT00508391

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Indication Fulfill
Item
meet the indications for therapy
boolean
C0087111 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Heart implantation | Left ventricle Pacing Threshold | Margin of safety Volt Quantity | Phrenic Nerve Stimulation Absent
Item
successfully implanted with a biotronik lumax hf-t crt-d system and have received sim for a minimum of 30 days prior to enrollment. a successful implantation is defined as having a measured lv pacing threshold which allows for a minimum 1-volt safety margin without any phrenic nerve stimulation at the time of enrollment.
boolean
C1293382 (UMLS CUI [1])
C0225897 (UMLS CUI [2,1])
C0199640 (UMLS CUI [2,2])
C0449864 (UMLS CUI [2,3])
C0243168 (UMLS CUI [3,1])
C0439502 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1737692 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Pharmaceutical Preparations Stable Congestive heart failure | Angiotensin-Converting Enzyme Inhibitors Dosage Therapeutic | Angiotensin II receptor antagonist Dosage Therapeutic | Adrenergic beta-Antagonists Dosage Stable | Indication for Heart failure | Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Adrenergic beta-Antagonists | Eplerenone Dosage Stable | Diuretics | Euvolemia | Angiotensin-Converting Enzyme Inhibitors Substitution Dosage Stable
Item
treated with stable and optimal chf medications, which includes an ace inhibitor (ace-i) or angiotensin receptor blocker (arb) at therapeutic dose for 1 month prior to enrollment, if tolerated, and a beta blocker that is approved and indicated for hf for 3 months prior to enrollment, if tolerated, with a stable dosage for 1 month prior to enrollment. if the patient is intolerant of ace-i or beta blockers, documented evidence must be available. eplerenone requires dosage stability for 1 month prior to enrollment. diuretics may be used as necessary to keep the patient euvolemic. therapeutic equivalence for ace-i substitutions is allowed within the enrollment stability timeliness. stable is defined as no more than a 100% increase or a 50% decrease in dose.
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0302350 (UMLS CUI [2,3])
C0521942 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0302350 (UMLS CUI [3,3])
C0001645 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0392360 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0003015 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0001645 (UMLS CUI [7,2])
C0961485 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
C0012798 (UMLS CUI [9])
C1845208 (UMLS CUI [10])
C0003015 (UMLS CUI [11,1])
C2936279 (UMLS CUI [11,2])
C0178602 (UMLS CUI [11,3])
C0205360 (UMLS CUI [11,4])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
able to understand the nature of the study and give informed consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Testing Completion | 6-minute walk test Completion | Quality of life Questionnaire Completion
Item
able to complete all testing required by the clinical protocol, including the 6-minute walk test and qol questionnaire
boolean
C0039593 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0430515 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0518214 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Availability Follow-up visit
Item
available for follow-up visits on a regular basis at the investigational site
boolean
C0470187 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Quantity Fulfill
Item
meet one or more of the contraindications
boolean
C1301624 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Life Expectancy
Item
have a life expectancy of less than 6 months
boolean
C0023671 (UMLS CUI [1])
Heart Transplantation Expected
Item
expected to receive heart transplantation within 6 months
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Hospitalization Quantity Congestive heart failure
Item
have had more than 1 chf-related hospitalization within past 30 days
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,3])
Inotropic agent Intravenous
Item
currently receiving iv inotropic medications
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Chronic atrial fibrillation
Item
chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Study Subject Participation Status | Scientific investigation Cardiovascular | Pharmacological study
Item
enrolled in another cardiovascular or pharmacological clinical investigation, except for fda required post-market registries
boolean
C2348568 (UMLS CUI [1])
C0683933 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
C1831759 (UMLS CUI [3])
Condition Preventing Testing
Item
any condition preventing the patient from being able to perform required testing
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Comorbidity Life Threatening | Heart Disease Separated
Item
presence of another life-threatening, underlying illness separate from their cardiac disorder
boolean
C0009488 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
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