The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Coronary Artery Disease, Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Helios Heart Registry: A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases: Application of the ICHOM Standard in Clinical Practice
Overview
Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.
Detailed description
Heart failure (HF), coronary artery disease (CAD) and atrial fibrillation (AF) are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence. Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce. The International Consortium for Health Outcomes Measurement (ICHOM) defined standard variable sets for all three diseases in order to objectively monitor the course of disease.
To evaluate current health care utilization and interactions between diseases and treatments in patients with HF, CAD and AF as well as patient-oriented values study initiator will build a prospective, observational, multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations.
Primary outcome measures
- All-cause mortality during f/u [Time frame: 6 months]
- All-cause mortality during f/u [Time frame: 12 months]
- All-cause mortality during f/u [Time frame: 18 months]
Secondary outcome measures (12)
- in-hospital mortality [Time frame: 3 days]
- cardiovascular mortality during f/u [Time frame: 6 months]
- cardiovascular mortality during f/u [Time frame: 12 months]
- cardiovascular mortality during f/u [Time frame: 18 months]
- length of hospital stay [Time frame: 3 days]
- rate of rehospitalizations of any cause during f/u [Time frame: 6 months]
- rate of rehospitalizations of any cause during f/u [Time frame: 12 months]
- rate of rehospitalizations of any cause during f/u [Time frame: 18 months]
- rate of rehospitalizations for cardiovascular causes during f/u [Time frame: 6 months]
- rate of rehospitalizations for cardiovascular causes during f/u [Time frame: 12 months]
- rate of rehospitalizations for cardiovascular causes during f/u [Time frame: 18 months]
- rate of rehospitalizations for specific cardiovascular diseases [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age of 18 years or older
- Inpatient Treatment
- Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF
Exclusion criteria
- Inability to provide informed consent
- Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock
- Patient after heart transplantation or patient with present ventricular assist device (VAD)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 10 centers
- Helios Klinikum Berlin-Buch — Berlin
- Helios Klinikum Erfurt — Erfurt
- Helios Klinikum Gifhorn — Gifhorn
- Helios Klinikum Hildesheim — Hildesheim
- Heart Center Leipzig at University of Leipzig — Leipzig
- Helios Vogtlandklinikum Plauen — Plauen
- Helios Klinikum Schwerin — Schwerin
- Helios Klinikum Siegburg — Siegburg
- … and 2 more centers
Publications
- Leiner J, Hohenstein S, Konig S, Kwast S, Nitsche A, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Muller M, Schulte N, Bode K, Kuhlen R, Bollmann A. Characteristics and outcomes of patients with heart failure and reduced left ventricular ejection fraction in relation to sodium-glucose cotransporter-2 inhibitor treatment: real-world data from PMID 41627441
- Leiner J, Konig S, Nitsche A, Hohenstein S, Nagel J, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Kuhlen R, Bollmann A. A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry. ESC Heart Fail. 2025 Aug;12(4):3114-3133. doi: 10.1002/ehf2.15266. Epub 2025 Apr 13. PMID 40222816
Identifiers
NCT: NCT04844944 · 2021-0016