The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Heart Failure, Coronary Artery Disease, Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br>Hospitalized patients diagnosed with Heart Failure. No Intervention. | |
| Coronary Artery Disease<br>Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention. | |
| Atrial Fibrillation<br>Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality |  | 3 days | 
| cardiovascular mortality during f/u |  | 6 months | 
| cardiovascular mortality during f/u |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, HF, CAD, AF, ICHOM