Biomarkers to Classify Heart Failure
Biomarkers to Classify Heart Failure
The purpose of this study is to evaluate existing biomarkers and see if they can be used to
 accurately diagnose the etiology of heart failure.
This is a cohort study consisting of 2 patient cohorts. The first cohort will be studied
 retrospectively, using existing blood samples from different biobanks. Biomarkers will be
 measured and matched with the etiology of previously diagnosed heart failure by a biomarker
 panel of heart failure experts. This cohort consists of 100 patients each with (1) ischemic
 cardiomyopathy, (2) dilated cardiomyopathy and (3) diastolic heart failure. Blood samples
 will be analyzed for novel biomarkers. Investigators will be seeking biomarker candidate(s)
 alone or in combination which can predict each category of heart failure etiology with over
 85% accuracy and the lowest levels of reclassification. A panel of heart failure experts will
 be assembled, and the appropriate cut-off values determined. Once this goal has been
 achieved, the prospective study will go ahead.

 In the second cohort, biomarkers will be measured and used to diagnose the etiology of heart
 failure for each subject. This diagnosis will then be compared to the diagnosis from results
 of the usual diagnostic tests. Investigators will recruit 450 patients admitted to hospital
 or outpatient clinics with recently diagnosed heart failure (<2 years) and test for different
 biomarkers. Using the biomarker values, investigators will predict their heart failure
 etiology in an objective manner. The patients will then undergo definitive etiological workup
 as usual to establish the actual etiology of the heart failure. The duration of a typical
 etiological workup is about 3 days for hospitalized patients and up to 8 weeks for patients
 admitted to outpatient clinics. The predictive accuracy of the new heart failure panel will
 be compared to clinical assessment.

 Investigators will perform cost-modeling in terms of the potential savings in avoiding
 unnecessary coronary angiographies or perfusion scans in a typical mixed cohort of heart
 failure patients based on the marker determined etiology.

 A group of healthy volunteers will be added. This group will serve as age matched controls to
 the prospective cohort of heart failure patients.
Inclusion Criteria:

 -  Patients admitted with symptomatic heart failure, diagnosed within 2 years.

 -  Diagnosis of congestive heart failure using the modified Framingham criteria:

 Simultaneous presence of at least 2 major criteria or 1 major criterion in conjunction with
 2 minor criteria or a previous clear diagnosis of heart failure.

 Major criteria:

 -  Paroxysmal nocturnal dyspnea or orthopnea

 -  Neck vein distention

 -  Rales/Crackles (>10 cm from base of lungs)

 -  Acute pulmonary edema

 -  S3 gallop

 -  Increased central venous pressure (>16 cm H2O at right atrium)

 -  Hepatojugular reflux

 -  Weight loss >4.5 kg in 5 days in response to treatment Echocardiographic left
 ventricular dysfunction

 Minor criteria:

 -  Bilateral ankle edema

 -  Nocturnal cough

 -  Dyspnea on exertion

 -  Hepatomegaly

 -  Pleural effusion

 -  Weight loss >4.5 kg caused by heart failure where factors other than treatment of CHF
 could have contributed to the weight loss

 -  Tachycardia (heart rate >120 beats/min) Minor criteria are acceptable only if they
 cannot be attributed to another medical condition (such as pulmonary hypertension,
 chronic lung disease, cirrhosis, ascites, or the nephrotic syndrome).

 Exclusion Criteria:

 -  Patients unable to provide blood sample

 -  Patients unable to provide consent

 -  Patient with life expectancy of less than 6 months, or has major co-morbidities.

 -  Any other significant disease or disorder which, in the opinion of the Investigator,
 may either put the participants at risk because of participation in the trial, or may
 influence the result of the trial, or the participant's ability to participate in the
 trial.

 -  Participants who have participated in another research trial involving an
 investigational product in the past 30 days.