Critical Diagnostics announced today that a paper titled, "The Effect of Left Ventricle Remodelling On Soluble ST2 in A Cohort of Hypertensive Subjects," published in Journal of Human Hypertension, showed that the Company's biomarker, ST2, was useful in not only differentiating hypertensive heart failure (HHF) patients from those with hypertension (HT) with or without left ventricular hypertrophy (LVH), but also distinguishes hypertensive LVH from hypertension without LVH.

These are important findings because, as the authors note, "subjects with longstanding or severe HT (hypertension) have an increased risk of developing LVH (left ventricular hypertrophy) and subsequently heart failure."

High blood pressure, or hypertension, is a major health problem, affecting 67 million Americans, or one in every three adults. Hypertension is a leading risk factor for cardiovascular disease. According to the Centers for Disease Control, people with high blood pressure--normally defined as above 140/90 mmHg1--are four times more likely to die from stroke and three times more likely to die from heart disease than people with normal blood pressure.

Although electrocardiology (ECG) and echocardiography are useful in differentiating the various spectrum of hypertensive heart disease, they have their limitations. The findings from this work show ST2 can assist in differentiating the three prognostic patterns of uncomplicated HT from two of its major cardiac complications and may also become useful in the choice of specific antihypertensive agents. The authors note, "As it is well known that LVH often progresses to heart failure, early diagnosis of hypertensive LVH and its treatment with angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) will therefore, in no small [way], reduce the burden of HHF, which is the commonest form of heart failure in our environment."

The study also looked at another popular biomarker, NT-proBNP. Results showed quite conclusively that ST2 was superior to NT-proBNP in differentiating hypertension from hypertensive heart failure and was also better at distinguishing hypertensive LVH from hypertensive heart failure.

This prospective in-hospital and out-patient study involved just over 200 subjects with a diagnosis of hypertension and hypertensive heart failure from sub-Saharan Africa, in this case, Nigeria. Black population groups tend to develop high blood pressure at younger ages than other groups and are more likely to develop complications associated with high blood pressure.

Left ventricular hypertrophy results in response to some factor, such as high blood pressure, that requires the left ventricle to work hard, and to compensate, the walls of the heart thicken and lose elasticity. There is widespread agreement that LVH is an important intermediate phenotype in the progression of hypertensive heart disease.2

Study investigators also found an association between ST2 and LV ejection fraction. "As LV ejection is a strong prognostic factor in heart failure," state the authors, "our data therefore suggest that plasma ST2 could be a good prognostic marker of heart failure in hypertensive subjects."

Moreover, a strong link between ST2 and echocardiographic LV diastolic function was shown. "Therefore, plasma ST2 is not only correlated with systolic function but also with diastolic function in a cohort of our hypertensive subjects," remark the authors, adding, "On the other hand, there was no significant correlation between NT-proBNP and all indices of diastolic function assessed in our study cohort, similar to previous studies."

"This study builds on the strong body of evidence we already have showing the powerful predictive value of ST2," declares David M. Geliebter, CEO of Critical Diagnostics. "What's particularly interesting is how the investigators identified this subset of patients likely to advance to heart failure or a worsening stage of heart failure, because we know that in half the patients that advance to Stage C, cost of care rises dramatically and 5-year survival rates fall quite precipitously. So having a biomarker that can help health care professionals refine the discrimination within hypertensive patients and those in early stages of heart failure and then treat them accordingly, can save and improve lives and, at the same time, reduce the burden to the healthcare system."

About ST2

ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient's condition--thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. All this makes ST2 an ideal serial biomarker for monitoring and treating heart failure patients.

The 2013 ACC/AHA Guideline For The Management of Heart Failure, recognizes ST2 as "not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in [its] prognostic value."

The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker test in the world. The Presage ST2 Assay has been CE Marked and cleared by the U.S. FDA for use as in the risk stratification of chronic heart failure patients.

About Critical Diagnostics

Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners for its Presage ST2 Assay in 45 countries, covering two-thirds of the world's population.

1 Millimeters of mercury

2 "The progression of Hypertensive Heart Disease," Mark H. Drazner, MD, Circ, Jan 2011

Critical Diagnostics
Dennis Dalangin, +1 877-700-1250
VP Marketing
ddalangin@criticaldiagnostics.com