The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases (H²-Registry)

Helios Health Institute GmbH

Status: Enrolling

Conditions: Coronary Artery Disease; Atrial Fibrillation; Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT04844944

2021-0016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

24,000 participants in 3 patient groups

Heart Failure

Description:

Hospitalized patients diagnosed with Heart Failure. No Intervention.

Coronary Artery Disease

Description:

Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention.

Atrial Fibrillation

Description:

Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention.