ID

12631

Description

An Observational Study of the Functional Capacity of Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02350114

Link

https://clinicaltrials.gov/show/NCT02350114

Keywords

Versions (1)
  1. 12/7/15 12/7/15 -
Uploaded on

December 7, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02350114

English

Eligibility Acute Heart Failure NCT02350114

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a left ventricular ejection fraction (lvef) 40 percent, as assessed by any method, e.g., echocardiography, a multigated acquisition (muga) scan or magnetic resonance imaging (mri);
Description

left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
present with signs and symptoms considered to be primarily due to ahf and be admitted to the hospital for ahf;
Description

hospitalization with signs and symptoms of ahf

Data type

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0019993
confirmation verbally that the patient was ambulatory, i.e., able to walk >30m, prior to developing symptoms of ahf leading to the current admission;
Description

Patient is ambulatory prior to admission

Data type

boolean

Alias
UMLS CUI [1]
C3693818
be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a systolic blood pressure <90mmhg or >170mmhg at baseline;
Description

systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter;
Description

have an anticipated need for an invasive procedure within 3 days of study enrollment

Data type

boolean

Alias
UMLS CUI [1]
C1548804
have a primary hf etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation);
Description

have a primary hf etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy that is obstructive, or uncorrected severe valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0878544
UMLS CUI [3]
C3258293
have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, copd, arthritis or other condition, as confirmed verbally with the patient;
Description

have any other comorbidities that limit ambulation more than the patient's heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
have severe renal insufficiency (defined as a gfr <30ml/min/1.73m2 according to the mdrd equation);
Description

have severe renal insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0035078
have an anticipated survival of less than 90 days, for any reason;
Description

have an anticipated survival of less than 90 days

Data type

boolean

Alias
UMLS CUI [1]
C0023671
have received an investigational agent (drug, device or biologic product) within 30 days (or, if longer, 5 half-lives for a drug or biologic agent) prior to study entry, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least study day 35;
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigators opinion, makes it inappropriate for the patient to participate in this clinical trial.
Description

have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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Similar models

Eligibility Acute Heart Failure NCT02350114

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
left ventricular ejection fraction
Item
have a left ventricular ejection fraction (lvef) 40 percent, as assessed by any method, e.g., echocardiography, a multigated acquisition (muga) scan or magnetic resonance imaging (mri);
boolean
C0428772 (UMLS CUI [1])
hospitalization with signs and symptoms of ahf
Item
present with signs and symptoms considered to be primarily due to ahf and be admitted to the hospital for ahf;
boolean
C0264714 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Patient is ambulatory prior to admission
Item
confirmation verbally that the patient was ambulatory, i.e., able to walk >30m, prior to developing symptoms of ahf leading to the current admission;
boolean
C3693818 (UMLS CUI [1])
Informed consent
Item
be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systolic blood pressure
Item
have a systolic blood pressure <90mmhg or >170mmhg at baseline;
boolean
C0871470 (UMLS CUI [1])
have an anticipated need for an invasive procedure within 3 days of study enrollment
Item
have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter;
boolean
C1548804 (UMLS CUI [1])
have a primary hf etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy that is obstructive, or uncorrected severe valvular disease
Item
have a primary hf etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation);
boolean
C0018801 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C3258293 (UMLS CUI [3])
have any other comorbidities that limit ambulation more than the patient's heart failure
Item
have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, copd, arthritis or other condition, as confirmed verbally with the patient;
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
have severe renal insufficiency
Item
have severe renal insufficiency (defined as a gfr <30ml/min/1.73m2 according to the mdrd equation);
boolean
C0035078 (UMLS CUI [1])
have an anticipated survival of less than 90 days
Item
have an anticipated survival of less than 90 days, for any reason;
boolean
C0023671 (UMLS CUI [1])
study subject participation status
Item
have received an investigational agent (drug, device or biologic product) within 30 days (or, if longer, 5 half-lives for a drug or biologic agent) prior to study entry, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least study day 35;
boolean
C2348568 (UMLS CUI [1])
have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
Item
have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigators opinion, makes it inappropriate for the patient to participate in this clinical trial.
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
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