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
{"title":"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","authors":"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","doi":"10.1002/ehf2.15266","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>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 (H<sup>2</sup>)-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.</p>\n </section>\n \n <section>\n \n <h3> Methods and results</h3>\n \n <p>The H<sup>2</sup>-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.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The H<sup>2</sup>-registry is currently the largest ongoing prospective registry of HF patients in Germany. It is foreseeable that the H<sup>2</sup>-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.</p>\n \n <p>Trial registration number: NCT04844944.</p>\n </section>\n </div>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":"12 4","pages":"3114-3133"},"PeriodicalIF":3.7000,"publicationDate":"2025-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ehf2.15266","citationCount":"0","resultStr":"{\"title\":\"A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry\",\"authors\":\"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\",\"doi\":\"10.1002/ehf2.15266\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>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 (H<sup>2</sup>)-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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods and results</h3>\\n \\n <p>The H<sup>2</sup>-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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>The H<sup>2</sup>-registry is currently the largest ongoing prospective registry of HF patients in Germany. 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A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry
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.
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.
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