Project B

• To use and prove value of the infrastructure by a prospective randomized clinical research on pharmaco-therapeutic treatment in patients with chronic heart failure.

Despite improvements in treatment, heart failure (HF) still carries a substantial risk of morbidity and mortality. Currently, 240,000 patients are living with HF in the Netherlands. Further refinements in care are needed and acceleration of research findings into clinical practice is warranted to improve outcome. The digitisation of healthcare provides the opportunity to enable a learning healthcare system through re-using data from routine clinical practice, which could shorten the innovation loop from research to practice.

The aim of the Heart4Data consortium is to create a national and sustainable infrastructure for cardiovascular electronic health record (EHR)-based, registry-based research in the Netherlands. SELEQT-HF will be the first registry based randomized clinical trial (RB-RCT) to test the infrastructure as proof-of-concept study.

The proposed infrastructure will be tested in a low-risk RB-RCT with respect to patient-safety. Therefore, we choose to study the clinical benefit of Selenium/CoQ10, a dietary supplement, in patients with HF. Selenium/CoQ10 supplements are safe and have no known side effects and can therefore be given to all patients presenting with HF. Here, the effect of Selenium/CoQ10 treatment on repeated HF hospitalizations and cardiovascular death in patients with HF will be evaluated.

• June 1, 2023: Consortium agreement signed