Standardised and hierarchically classified heart failure and complementary disease monitoring outcome measures: european Unified Registries for heart Care evaluation and randomised trials (EuroHeart)

Aims: The lack of standardised definitions for heart failure outcome measures limits the ability to reliably assess effectiveness of heart failure therapies. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) aimed to produce a catalogue of internationally endorsed data definitions for heart failure outcome measures. Methods: Following the EuroHeart methods for the development of cardiovascular data standards, a working group was formed of representatives from the European Society of Cardiology Heart Failure Association and other leading heart failure experts. A systematic review of observational and randomised clinical trials identified current outcome measures, which was supplemented by clinical practice guidelines and existing registries for contemporary definitions. A modified Delphi process was employed to gain consensus for variable inclusion and whether collection should be mandatory (Level 1) or optional (Level 2) within EuroHeart. In addition, a set of complementary outcome measures were identified by the Working Group as of scientific and clinical importance for longitudinal monitoring for people with heart failure. Results: Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure. Conclusion: We present a structured, hierarchical catalogue of internationally endorsed heart failure outcome measures. This will facilitate quality improvement, high quality observational research, registry-based trials, and post market surveillance of medical devices.