Cardiovascular Disease

Global health problem – unmet medical need
Cardiovascular disease (CVD) is the leading cause of death worldwide taking an estimated 17.9 million lives each year (https://www.who.int), a large proportion of these patients ultimately die from sudden cardiac death (SCD). The predominant causes of SCD – ventricular tachycardia and ventricular fibrillation (VT/VF) – have been shown to be key determinants of survival in patients with diagnosed and undiagnosed CVD. 

Cardiomyocyte Ca²⁺ imbalance is at the core of most triggered arrhythmias in CVD, but current biomarkers (troponins and BNP) do not reflect Ca²⁺ regulation. Accordingly, methods to identify and monitor patients with cardiomyocyte Ca²⁺ imbalance and increased risk of VT/VF are highly warranted. As the only biomarker associated with Ca²⁺ status, secretoneurin (SN) is ideally suited for this purpose. Moreover, high SN concentrations are also a strong indication of the need to follow up with ECGs, echocardiography, and other examinations (angiography, cardiac MRI, PET-CT, etc.) to determine whether there are signs of structural or functional heart disease.

There is a potential major role for secretoneurin testing in patient selection for cardiac rhythm management. Current criteria both lack the desired sensitivity and specificity. As an example, as many as 70% of patients with an ICD (implantable cardioverter-defibrillator) will never need the device. Conversely, a large proportion of sudden cardiac death patients do not fulfil current criteria for ICD implantation. Thus, there is an urgent need to better target and select patients who will benefit from an ICD. The arrhythmia-ICD market is massive: It is estimated that over 30 million people suffer from arrhythmias and over 100.000 ICDs are implanted in the EC alone with yearly device treatment costs exceeding €2 billion.