Data from 1,200 heart failure patients demonstrate that high discharge levels of the biomarker bio-ADM® (bioactive Adrenomedullin) indicate residual congestion in heart failure patients.
The endothelial function marker bio-ADM of German diagnostics company SphingoTec GmbH reliably diagnosed tissue congestion and residual congestion in 1.200 patients enrolled in the PROTECT study, reports an international team of cardiologists headed by Adrian Voors from University Medical Center Groningen. Residual congestion is a currently unmet medical need that affects 25% of heart failure patients, who just apparently respond to diuretic therapy causing high mortality in patients post discharge from the hospital.
Elevated bio-ADM® blood plasma levels indicated not only insufficient response to diuretics but also were associatied with a substantially higher risk for short-therm rehospitalization and mortality. According Voors, the study data confirm bio-ADM® as a biomarker for tissue congestion, which is complementary to BNP as a biomarker for cardiac wall stress. Currently, there is no biomarker except bio-ADM® that identifies patients with residual congestion who need for continued therapeutic intervention with diuretics.
About 95% of patients with acute heart failure show fluid overload and tissue congestion, which can lead to lung edema as a fatal complication. Previous clinical data from more than 20,000 patients demonstrate that bio-ADM® plasma levels reflect endothelial function independently from inflammation and co-morbidities. High bio-ADM(R) levels indicate distortions in the barrier function of the endothelium causing fluid leakage into tissue. Today, 25% of acute heart failure patients discharged from hospitals are readmitted within 30 days, mostly because of residual congestion with subclinical manifestation at the time of discharge. Identification of patients with residual congestion may considerably reduce the risk of complications after the patient is discharged and decrease the need for readmission to the hospital.
"By providing diagnostic tools that support a more informed management of heart failure patients we achieve another milestone in our strategy to fight mortality in critically ill patients," said Dr. Andreas Bergmann, founder and CEO of sphingotec.
sphingotec develops novel biomarkers for the diagnosis of critical care conditions and makes them available as rapid tests on its point-of-care immunoassay analyzer, Nexus IB10. In addition to the assays for sphingotec's properitary biomarkers, the IB10 platfrom features a broad menu of routine tests for critical care and other conditions that benefit from rapid testing in near-patient settings.
An antibody targeting bio-ADM® is in Phase II development.