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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

24000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2026-03-01

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.

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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.

Conditions

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Heart Failure Coronary Artery Disease Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure

Hospitalized patients diagnosed with Heart Failure. No Intervention.

No interventions assigned to this group

Coronary Artery Disease

Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention.

No interventions assigned to this group

Atrial Fibrillation

Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention.

No interventions assigned to this group

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Bollmann, MD, PhD

Role: STUDY_CHAIR

Heart Center at University of Leipzig

Locations

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