A Multicentre Registry of Hospitalized Patients with Acute and Chronic Heart Failure: Study Design of the H2-Registry

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Abstract Aims Heart failure (HF) is a highly prevalent condition affecting 1–3% of the adult population in Europe. Despite landmark improvements in HF care over the last two decades, hospitalization and mortality rates remain relatively high. Gathering real-world data on HF populations is crucial, especially in the light of newly emerging therapeutic approaches. The Helios Heart (H2)-registry was established to provide up-to-date, real-world data on a contemporary cohort of hospitalized HF patients in Germany using a standardized set of outcome measures with a focus on patient-reported outcomes (PROs). This manuscript describes the registry's design and presents an interim analysis of baseline characteristics and 1-year outcomes. Methods and results The H2-registry is a prospective, investigator-initiated, multicentre observational registry in Germany that started in 2021 and is actively enrolling patients. Inpatients ≥18 years of age with a present diagnosis of chronic or acute HF are recruited in secondary and tertiary hospitals throughout Germany. Routine follow-up (FU) is conducted every 6 months. Data collection is based on a set of variables following recommendations of the International Consortium of Health Outcome Measurements (ICHOM) covering data on demographics, medical history, HF characteristics, medication, procedures, and patients' perceived health status via the collection of standardized PROs. Until 31 December 2023, a total of 2361 patients were enrolled in 10 study centres. Mean age in this cohort is 72 years, 36.9% are female, and median left ventricular ejection fraction is 45%. An analysis of 6-month and 12-month outcomes in a cohort of 1593 patients with complete FU data revealed all-cause mortality rates of 9.0% and 16.2% at 6 and 12 months, while HF-related rehospitalizations occurred in 24.4% and 43.5% at 6 and 12 months. Conclusions The H2-registry is currently the largest ongoing prospective registry of HF patients in Germany. It is foreseeable that the H2-registry will significantly contribute to the collection of real-world data and provide a comprehensive and unique perspective on the current characteristics, treatment strategies, and resulting outcomes of HF patients in Germany. Trial registration number: NCT04844944.

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