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

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

Recruiting
18 years and older
All
Phase N/A

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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.

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.

Eligibility

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)

Study details
    Heart Failure
    Coronary Artery Disease
    Atrial Fibrillation

NCT04844944

Helios Health Institute GmbH

27 January 2024

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