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

Coronary Artery Disease Clinical Trial

— H²-Registry  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844944
• Other study ID #: 2021-0016
• Status: Recruiting
• Start date: March 30, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2023
• Source: Helios Health Institute GmbH
• Contact: Andreas Bollmann, MD, PhD
• Phone: +49 341 865-1413
• Email: Andreas.bollmann[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Heart Diseases
• Heart Failure

Locations

Country	Name	City	State
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Helios Klinikum Gifhorn	Gifhorn
Germany	Helios Klinikum Hildesheim	Hildesheim
Germany	Heart Center Leipzig at University of Leipzig	Leipzig
Germany	Helios Vogtlandklinikum Plauen	Plauen
Germany	Helios Klinikum Schwerin	Schwerin
Germany	Helios Klinikum Siegburg	Siegburg
Germany	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden
Germany	Helios Universitätsklinikum Wuppertal	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Helios Health Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality during f/u		6 months
Primary	All-cause mortality during f/u		12 months
Primary	All-cause mortality during f/u		18 months
Secondary	in-hospital mortality		3 days
Secondary	cardiovascular mortality during f/u		6 months
Secondary	cardiovascular mortality during f/u		12 months
Secondary	cardiovascular mortality during f/u		18 months
Secondary	length of hospital stay		3 days
Secondary	rate of rehospitalizations of any cause during f/u		6 months
Secondary	rate of rehospitalizations of any cause during f/u		12 months
Secondary	rate of rehospitalizations of any cause during f/u		18 months
Secondary	rate of rehospitalizations for cardiovascular causes during f/u		6 months
Secondary	rate of rehospitalizations for cardiovascular causes during f/u		12 months
Secondary	rate of rehospitalizations for cardiovascular causes during f/u		18 months
Secondary	rate of rehospitalizations for specific cardiovascular diseases		6 months
Secondary	rate of rehospitalizations for specific cardiovascular diseases		12 months
Secondary	rate of rehospitalizations for specific cardiovascular diseases		18 months
Secondary	rate of specific cardiovascular events		6 months
Secondary	rate of specific cardiovascular events		12 months
Secondary	rate of specific cardiovascular events		18 months
Secondary	general quality of life (PROMIS)		6 months
Secondary	general quality of life (PROMIS)		12 months
Secondary	general quality of life (PROMIS)		18 months
Secondary	general quality of life (PHQ2)		6 months
Secondary	general quality of life (PHQ2)		12 months
Secondary	general quality of life (PHQ2)		18 months
Secondary	disease specific quality of life (KCCQ-12 [HF])		6 months
Secondary	disease specific quality of life (KCCQ-12 [HF])		12 months
Secondary	disease specific quality of life (KCCQ-12 [HF])		18 months
Secondary	disease specific quality of life (SAQ-7 [CAD])		6 months
Secondary	disease specific quality of life (SAQ-7 [CAD])		12 months
Secondary	disease specific quality of life (SAQ-7 [CAD])		18 months
Secondary	disease specific quality of life (AFEQT [AF])		6 months
Secondary	disease specific quality of life (AFEQT [AF])		12 months
Secondary	disease specific quality of life (AFEQT [AF])		18 months
Secondary	side effects associated with drug treatment	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.	6 months
Secondary	side effects associated with drug treatment	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.	12 months
Secondary	side effects associated with drug treatment	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.	18 months
Secondary	complications associated with therapeutic interventions	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.	6 months
Secondary	complications associated with therapeutic interventions	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.	12 months
Secondary	complications associated with therapeutic interventions	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.	18 months
Secondary	adherence to therapy	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.	6 months
Secondary	adherence to therapy	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.	12 months
Secondary	adherence to therapy	The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.	18 months
Secondary	disease associated treatment costs		6 months
Secondary	disease associated treatment costs		12 months
Secondary	disease associated treatment costs		18 months