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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Hospitalized patients diagnosed with Heart Failure. No Intervention. | ||
| Coronary Artery Disease | Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention. | ||
| Atrial Fibrillation | Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality during f/u | 6 months | |
| All-cause mortality during f/u | 12 months | |
| All-cause mortality during f/u | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital mortality | 3 days | |
| cardiovascular mortality during f/u | 6 months | |
| cardiovascular mortality during f/u |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being admitted as inpatients to a cardiology ward of one of the participating centers with one or more major cardiovascular disease entities (HF, CAD, AF)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Bollmann, MD, PhD | Contact | +49 341 865-1413 | Andreas.bollmann@helios-gesundheit.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Bollmann, MD, PhD | Heart Center at University of Leipzig | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Klinikum Berlin-Buch | Active, not recruiting | Berlin | 13125 | Germany | ||
| Helios Klinikum Erfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41627441 | Derived | 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 the multicentre H2-registry. Clin Res Cardiol. 2026 Feb 2. doi: 10.1007/s00392-026-02853-2. Online ahead of print. | |
| 40222816 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| D001281 | Atrial Fibrillation |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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| 12 months |
| cardiovascular mortality during f/u | 18 months |
| length of hospital stay | 3 days |
| rate of rehospitalizations of any cause during f/u | 6 months |
| rate of rehospitalizations of any cause during f/u | 12 months |
| rate of rehospitalizations of any cause during f/u | 18 months |
| rate of rehospitalizations for cardiovascular causes during f/u | 6 months |
| rate of rehospitalizations for cardiovascular causes during f/u | 12 months |
| rate of rehospitalizations for cardiovascular causes during f/u | 18 months |
| rate of rehospitalizations for specific cardiovascular diseases | 6 months |
| rate of rehospitalizations for specific cardiovascular diseases | 12 months |
| rate of rehospitalizations for specific cardiovascular diseases | 18 months |
| rate of specific cardiovascular events | 6 months |
| rate of specific cardiovascular events | 12 months |
| rate of specific cardiovascular events | 18 months |
| general quality of life (PROMIS) | 6 months |
| general quality of life (PROMIS) | 12 months |
| general quality of life (PROMIS) | 18 months |
| general quality of life (PHQ2) | 6 months |
| general quality of life (PHQ2) | 12 months |
| general quality of life (PHQ2) | 18 months |
| disease specific quality of life (KCCQ-12 [HF]) | 6 months |
| disease specific quality of life (KCCQ-12 [HF]) | 12 months |
| disease specific quality of life (KCCQ-12 [HF]) | 18 months |
| disease specific quality of life (SAQ-7 [CAD]) | 6 months |
| disease specific quality of life (SAQ-7 [CAD]) | 12 months |
| disease specific quality of life (SAQ-7 [CAD]) | 18 months |
| disease specific quality of life (AFEQT [AF]) | 6 months |
| disease specific quality of life (AFEQT [AF]) | 12 months |
| disease specific quality of life (AFEQT [AF]) | 18 months |
| side effects associated with drug treatment | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit. | 6 months |
| side effects associated with drug treatment | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit. | 12 months |
| side effects associated with drug treatment | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit. | 18 months |
| complications associated with therapeutic interventions | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities. | 6 months |
| complications associated with therapeutic interventions | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities. | 12 months |
| complications associated with therapeutic interventions | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities. | 18 months |
| adherence to therapy | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed. | 6 months |
| adherence to therapy | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed. | 12 months |
| adherence to therapy | The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed. | 18 months |
| disease associated treatment costs | 6 months |
| disease associated treatment costs | 12 months |
| disease associated treatment costs | 18 months |
| Active, not recruiting |
| Erfurt |
| 99089 |
| Germany |
| Helios Klinikum Gifhorn | Active, not recruiting | Gifhorn | 38518 | Germany |
| Helios Klinikum Hildesheim | Recruiting | Hildesheim | 31135 | Germany |
|
| Heart Center Leipzig at University of Leipzig | Active, not recruiting | Leipzig | 04289 | Germany |
| Helios Vogtlandklinikum Plauen | Active, not recruiting | Plauen | 08529 | Germany |
| Helios Klinikum Schwerin | Recruiting | Schwerin | 19049 | Germany |
|
| Helios Klinikum Siegburg | Active, not recruiting | Siegburg | 53721 | Germany |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden | Recruiting | Wiesbaden | 65199 | Germany |
|
| Helios Universitätsklinikum Wuppertal | Recruiting | Wuppertal | 42283 | Germany |
|
| Derived |
| 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |