Clinical trial NCT04844944: The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Coronary Artery Disease
Atrial Fibrillation
Keywords: cardiovascular disease
HF
CAD
AF
ICHOM
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 24000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being admitted as inpatients to a cardiology ward of one of the participating centers with one or more major cardiovascular disease entities (HF, CAD, AF)

Brief 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.

Detailed 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 criteria: 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)

Primary outcomes:
measure: All-cause mortality during f/u
timeFrame: 6 months
measure: All-cause mortality during f/u
timeFrame: 12 months
measure: All-cause mortality during f/u
timeFrame: 18 months
Secondary outcomes:
measure: in-hospital mortality
timeFrame: 3 days
measure: cardiovascular mortality during f/u
timeFrame: 6 months
measure: cardiovascular mortality during f/u
timeFrame: 12 months
measure: cardiovascular mortality during f/u
timeFrame: 18 months
measure: length of hospital stay
timeFrame: 3 days
measure: rate of rehospitalizations of any cause during f/u
timeFrame: 6 months
measure: rate of rehospitalizations of any cause during f/u
timeFrame: 12 months
measure: rate of rehospitalizations of any cause during f/u
timeFrame: 18 months
measure: rate of rehospitalizations for cardiovascular causes during f/u
timeFrame: 6 months
measure: rate of rehospitalizations for cardiovascular causes during f/u
timeFrame: 12 months
measure: rate of rehospitalizations for cardiovascular causes during f/u
timeFrame: 18 months
measure: rate of rehospitalizations for specific cardiovascular diseases
timeFrame: 6 months
measure: rate of rehospitalizations for specific cardiovascular diseases
timeFrame: 12 months
measure: rate of rehospitalizations for specific cardiovascular diseases
timeFrame: 18 months
measure: rate of specific cardiovascular events
timeFrame: 6 months
measure: rate of specific cardiovascular events
timeFrame: 12 months
measure: rate of specific cardiovascular events
timeFrame: 18 months
measure: general quality of life (PROMIS)
timeFrame: 6 months
measure: general quality of life (PROMIS)
timeFrame: 12 months
measure: general quality of life (PROMIS)
timeFrame: 18 months
measure: general quality of life (PHQ2)
timeFrame: 6 months
measure: general quality of life (PHQ2)
timeFrame: 12 months
measure: general quality of life (PHQ2)
timeFrame: 18 months
measure: disease specific quality of life (KCCQ-12 [HF])
timeFrame: 6 months
measure: disease specific quality of life (KCCQ-12 [HF])
timeFrame: 12 months
measure: disease specific quality of life (KCCQ-12 [HF])
timeFrame: 18 months
measure: disease specific quality of life (SAQ-7 [CAD])
timeFrame: 6 months
measure: disease specific quality of life (SAQ-7 [CAD])
timeFrame: 12 months
measure: disease specific quality of life (SAQ-7 [CAD])
timeFrame: 18 months
measure: disease specific quality of life (AFEQT [AF])
timeFrame: 6 months
measure: disease specific quality of life (AFEQT [AF])
timeFrame: 12 months
measure: disease specific quality of life (AFEQT [AF])
timeFrame: 18 months
measure: side effects associated with drug treatment
timeFrame: 6 months
measure: side effects associated with drug treatment
timeFrame: 12 months
measure: side effects associated with drug treatment
timeFrame: 18 months
measure: complications associated with therapeutic interventions
timeFrame: 6 months
measure: complications associated with therapeutic interventions
timeFrame: 12 months
measure: complications associated with therapeutic interventions
timeFrame: 18 months
measure: adherence to therapy
timeFrame: 6 months
measure: adherence to therapy
timeFrame: 12 months
measure: adherence to therapy
timeFrame: 18 months
measure: disease associated treatment costs
timeFrame: 6 months
measure: disease associated treatment costs
timeFrame: 12 months
measure: disease associated treatment costs
timeFrame: 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Gifhorn
country: Germany
facility: Helios Klinikum Gifhorn
city: Hildesheim
country: Germany
facility: Helios Klinikum Hildesheim
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig
city: Plauen
country: Germany
facility: Helios Vogtlandklinikum Plauen
city: Schwerin
country: Germany
facility: Helios Klinikum Schwerin
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
Study officials:
affiliation: Heart Center at University of Leipzig
name: Andreas Bollmann, MD, PhD
role: STUDY_CHAIR
References: