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

Last updated: October 7, 2024
Sponsor: Helios Health Institute GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Thrombosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT04844944
2021-0016
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of 18 years or older

  • Inpatient Treatment

  • Present diagnosis of at least one of the three cardiovascular disease entities ofinterest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent

  • Initial presentation (index hospitalization) in cardiogenic shock or other kinds ofshock

  • Patient after heart transplantation or patient with present ventricular assistdevice (VAD)

Study Design

Total Participants: 24000
Study Start date:
March 30, 2021
Estimated Completion Date:
March 01, 2026

Study 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.

Connect with a study center

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt, 99089
    Germany

    Site Not Available

  • Helios Klinikum Gifhorn

    Gifhorn, 38518
    Germany

    Site Not Available

  • Helios Klinikum Hildesheim

    Hildesheim, 31135
    Germany

    Active - Recruiting

  • Heart Center Leipzig at University of Leipzig

    Leipzig, 04289
    Germany

    Site Not Available

  • Helios Vogtlandklinikum Plauen

    Plauen, 08529
    Germany

    Site Not Available

  • Helios Klinikum Schwerin

    Schwerin, 19049
    Germany

    Active - Recruiting

  • Helios Klinikum Siegburg

    Siegburg, 53721
    Germany

    Site Not Available

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199
    Germany

    Active - Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283
    Germany

    Active - Recruiting

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