ID

23902

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00508391

Keywords

versioni (1)
  1. 17/07/17 17/07/17 -
Caricato su

17 luglio 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Congestive Heart Failure NCT00508391

Inglese

Eligibility Congestive Heart Failure NCT00508391

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the indications for therapy
Descrizione

Therapeutic procedure Indication Fulfill

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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
Descrizione

Age

Tipo di dati

boolean

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

Comprehension Study Protocol | Informed Consent

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Availability Follow-up visit

Tipo di dati

boolean

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

Exclusion Criteria

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

Medical contraindication Quantity Fulfill

Tipo di dati

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
Descrizione

Life Expectancy

Tipo di dati

boolean

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

Heart Transplantation Expected

Tipo di dati

boolean

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

Hospitalization Quantity Congestive heart failure

Tipo di dati

boolean

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

Inotropic agent Intravenous

Tipo di dati

boolean

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

Chronic atrial fibrillation

Tipo di dati

boolean

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

Study Subject Participation Status | Scientific investigation Cardiovascular | Pharmacological study

Tipo di dati

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
Descrizione

Condition Preventing Testing

Tipo di dati

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
Descrizione

Comorbidity Life Threatening | Heart Disease Separated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443299
Ritorna all'inizio della pagina

Similar models

Eligibility Congestive Heart Failure NCT00508391

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial