The Re-Heart Registry: A Prospective, Interoperable, Standardised Clinical Registry of Outpatients With Heart Failure

Abstract

Purpose: To describe the creation and implementation of the RE-Heart Registry, a prospective, interoperable, highly scalable and standardised clinical registry of outpatients with heart failure (HF). Methods and Results: We carried out the steps, as follows: (1) data standardisation in accordance with national and international data elements. Dataset included all applicable standardised data elements published by the American Heart Association (AHA), American College of Cardiology (ACC) with the National Cardiovascular Data Registry (NCDR)and the Brazilian Cardiovascular Registries, as a reference the BREATHE (I Brazilian Registry of Heart Failure) and PINNACLE (heart failure and atrial fibrillation); (2) development of an initial data collection and clinical research workflow; (3) development of electronic case reports using REDCap and in accordance with the HIPAA privacy rule; (4) pilot test and validation of the data collection and clinical research workflows and CRFs; (5) development of automated data quality reporting using REDCap. Data collection occurs at the outpatient department at the moment of inclusion and every 6 months (phone calls and visits to the outpatients department). Conclusions: The RE-Heart Registry represents a comprehensive database capable to represent real clinical practice favouring clinical research, technology assessment, services management and health policies.