The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelios Health Institute GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
24,000 Participants
are grouped into 3 trial groupsGroup A: Heart Failure
Group B: Coronary Artery Disease
Group C: Atrial Fibrillation
Trial outcomes
Primary outcomes
1
All-cause mortality during f/u
Time frame
6 months2
All-cause mortality during f/u
Time frame
12 months3
All-cause mortality during f/u
Time frame
18 monthsSecondary outcomes
1
in-hospital mortality
Time frame
3 days2
cardiovascular mortality during f/u
Time frame
6 months3
cardiovascular mortality during f/u
Time frame
12 months4
cardiovascular mortality during f/u
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov