Eligibility Acute Heart Failure NCT02350114

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StudyEvent: Eligibility
1. Eligibility Acute Heart Failure NCT02350114

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Acute Heart Failure NCT02350114