Hospitalization for Heart Failure
AE / SAE Number
integer
Was the subject hospitalized for this event?
boolean
Date of hospitalization
date
Was the event primary reason for hospitalization?
boolean
If No, specify the primary reason for hospitalization:
text
Record corresponding AE/SAE number
integer
If Yes, please record details on the Death Form
boolean
Clinical Symptoms of Heart Failure
Date of Onset
date
Time of Onset
time
New or worsening dyspnoea at rest
boolean
New or worsening dyspnoea on exertion
boolean
New or worsening orthopnoea
boolean
New or worsening PND (paroxymal nocturnal dyspnoea)
boolean
New or worsening peripheral oedema
boolean
New or worsening pulmonary crackles / crepitations
boolean
New or worsening elevated JVP (jugular venous pressure)
boolean
New or worsening third heart sounds ("S3") or gallop rhythm
boolean
New or worsening peripheral oedema
boolean
Please, specify below
boolean
Specify
text
Investigative Evidence of Structural or Functional Heart Disease
Chest X-Ray
Was a chest x-ray performed?
boolean
Please submit a copy of the chest x-ray report, if available
date
CTR >=0.5; If Yes, provide CTR, if available
boolean
Upper zone flow redistribution (cephalisation of pulmonary veins)
boolean
Interstitial pulmanory oedema
boolean
Alveolar pulmonary oedema
boolean
Pleural effusion(s)
boolean
If Yes, specify here
text
Other x-ray features consistent with heart failure
boolean
If Yes, specify
text
Echocardiography
Please submit a copy of the electrocardiogram report, if available
date
Was Left ventricular end diastolic diameter (LVEDD) documented?
boolean
(LVEDD)
float
Dilated left ventricle
boolean
Left ventricular hypertrophy
boolean
Was intraventricular septal thickness during diastole (IVSd) documented?
boolean
IVSd
float
Was left posterior wall thickness during diastole (LVPWd) documented?
boolean
LVPWd
float
Was ejection fraction (EF) documented?
boolean
EF
float
Left ventricular systolic dysfunction / impairment
Was the echocardiogram reported as showing left ventricular systolic dysfunction / impairment?
boolean
If Yes, was this systolic dysfunction / impairment reported to be:
text
If Other, specify
text
Was left atrial diameter documented?
boolean
Left atrial diameter
float
Dilated left atrium
boolean
Significant valvular heart disease
Significant valvular heart disease
boolean
Mitral stenosis
boolean
Mitral regurgitation
boolean
Tricuspid stenosis
boolean
Tricuspid regurgitation
boolean
Aortic stenosis
boolean
Aortic regurgitation
boolean
Other
boolean
Specify
text
Evidence of diastolic dysfunction
boolean
Specify
text
Other relevant echocardiogram findings
boolean
Specify
text
BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal proBNP)
Peak BNP/NT-proBNP value + the laboratory upper reference limit
BNP
Was peak value recorded?
boolean
Peak Value
float
Date sample taken
date
Upper limit of normal
float
Unit
text
NT-proBNP
Was peak value recorded?
boolean
Peak Value
float
Date sample taken
date
Upper limit of normal
float
Unit
text
Other Investigations
e.g., cardiac magnetic resonance imaging (CMRI), radionuclide ventriculogram scan (RNVG), pulmonary artery catheterization
boolean
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant findings
text
Date of Investigation
date
Treatment
During this event, did the subject receive any of the following specifically for the treatment of heart failure?
boolean
If Yes, please check all that apply
integer
If Other, specify
text
Date of Treatment
date
Description of Event
Describe signs and symptoms, results of investigations that provided evidence for a diagnosis of heart failure, treatment and outcome, including autopsy if appropriate. If you have already provided an adequate summary of the event on another accompanying event form or Adverse Event form, the information need not be duplicated here. A copy of the hospital discharge summary should be submitted.
text