A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry

IF 3.7 2区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

ESC Heart Failure Pub Date : 2025-04-13 DOI:10.1002/ehf2.15266

Johannes Leiner, Sebastian König, Anne Nitsche, Sven Hohenstein, Jana Nagel, Melchior Seyfarth, Henning Baberg, Alexander Lauten, Hans Neuser, Alexander Staudt, Jürgen Tebbenjohanns, René Andrié, Michael Niehaus, Markus W. Ferrari, Ralf Kuhlen, Andreas Bollmann

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引用次数: 0

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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急性和慢性心力衰竭住院患者的多中心登记：h2登记的研究设计

目的：心力衰竭（HF）是一种非常普遍的疾病，影响了欧洲1-3%的成年人。尽管在过去二十年中心衰治疗取得了里程碑式的进步，但住院率和死亡率仍然相对较高。收集心衰人群的真实数据至关重要，特别是考虑到新出现的治疗方法。Helios心脏（H2）注册中心的建立是为了提供德国住院HF患者当代队列的最新真实数据，使用一套标准化的结果测量方法，重点关注患者报告的结果（PROs）。本文描述了注册表的设计，并提出了基线特征和1年结果的中期分析。方法和结果：h2注册是一项前瞻性、研究者发起的多中心观察性注册，于2021年在德国启动，目前正在积极招募患者。在德国的二级和三级医院招募年龄≥18岁且目前诊断为慢性或急性心衰的住院患者。每6个月进行一次常规随访。数据收集基于一组变量，这些变量遵循国际健康结果测量协会（ICHOM）的建议，包括人口统计数据、病史、心衰特征、药物、程序和患者通过标准化pro收集的感知健康状况。截至2023年12月31日，共有2361名患者在10个研究中心入组。该队列的平均年龄为72岁，36.9%为女性，中位左室射血分数为45%。对1593例具有完整FU数据的患者的6个月和12个月结果的分析显示，6个月和12个月时的全因死亡率分别为9.0%和16.2%，而6个月和12个月时hf相关再住院率分别为24.4%和43.5%。结论：h2登记是目前德国最大的正在进行的心衰患者前瞻性登记。可以预见，h2登记将显著有助于收集真实世界的数据，并为德国HF患者的当前特征、治疗策略和结果提供全面而独特的视角。试验注册号：NCT04844944。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ESC Heart Failure Medicine-Cardiology and Cardiovascular Medicine

CiteScore

7.00

自引率

7.90%

发文量

461

审稿时长

12 weeks

期刊介绍： ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.