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

Sponsor

Leipzig Heart Institute GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04844944

Collaborator

HELIOS Kliniken GmbH (Other)

24,000

Enrollment

Locations

42.1

Anticipated Duration (Months)

2400

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Coronary Artery Disease Atrial Fibrillation

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

24000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 30, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Heart Failure Hospitalized patients diagnosed with Heart Failure. No Intervention.
Coronary Artery Disease Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention.
Atrial Fibrillation Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention.

Outcome Measures

Primary Outcome Measures

All-cause mortality during f/u [6 months]
All-cause mortality during f/u [12 months]
All-cause mortality during f/u [18 months]

Secondary Outcome Measures

in-hospital mortality [3 days]
cardiovascular mortality during f/u [6 months]
cardiovascular mortality during f/u [12 months]
cardiovascular mortality during f/u [18 months]
length of hospital stay [3 days]
rate of rehospitalizations of any cause during f/u [6 months]
rate of rehospitalizations of any cause during f/u [12 months]
rate of rehospitalizations of any cause during f/u [18 months]
rate of rehospitalizations for cardiovascular causes during f/u [6 months]
rate of rehospitalizations for cardiovascular causes during f/u [12 months]
rate of rehospitalizations for cardiovascular causes during f/u [18 months]
rate of rehospitalizations for specific cardiovascular diseases [6 months]
rate of rehospitalizations for specific cardiovascular diseases [12 months]
rate of rehospitalizations for specific cardiovascular diseases [18 months]
rate of specific cardiovascular events [6 months]
rate of specific cardiovascular events [12 months]
rate of specific cardiovascular events [18 months]
general quality of life (PROMIS) [6 months]
general quality of life (PROMIS) [12 months]
general quality of life (PROMIS) [18 months]
general quality of life (PHQ2) [6 months]
general quality of life (PHQ2) [12 months]
general quality of life (PHQ2) [18 months]
disease specific quality of life (KCCQ-12 [HF]) [6 months]
disease specific quality of life (KCCQ-12 [HF]) [12 months]
disease specific quality of life (KCCQ-12 [HF]) [18 months]
disease specific quality of life (SAQ-7 [CAD]) [6 months]
disease specific quality of life (SAQ-7 [CAD]) [12 months]
disease specific quality of life (SAQ-7 [CAD]) [18 months]
disease specific quality of life (AFEQT [AF]) [6 months]
disease specific quality of life (AFEQT [AF]) [12 months]
disease specific quality of life (AFEQT [AF]) [18 months]
side effects associated with drug treatment [6 months]
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.
side effects associated with drug treatment [12 months]
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.
side effects associated with drug treatment [18 months]
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.
complications associated with therapeutic interventions [6 months]
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.
complications associated with therapeutic interventions [12 months]
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.
complications associated with therapeutic interventions [18 months]
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.
adherence to therapy [6 months]
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.
adherence to therapy [12 months]
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.
adherence to therapy [18 months]
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.
disease associated treatment costs [6 months]
disease associated treatment costs [12 months]
disease associated treatment costs [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Helios Klinikum Berlin-Buch	Berlin	Germany	13125
2	Helios Klinikum Erfurt	Erfurt	Germany	99089
3	Helios Klinikum Gifhorn	Gifhorn	Germany	38518
4	Helios Klinikum Hildesheim	Hildesheim	Germany	31135
5	Heart Center Leipzig at University of Leipzig	Leipzig	Germany	04289
6	Helios Vogtlandklinikum Plauen	Plauen	Germany	08529
7	Helios Klinikum Schwerin	Schwerin	Germany	19049
8	Helios Klinikum Siegburg	Siegburg	Germany	53721
9	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden	Germany	65199
10	Helios Universitätsklinikum Wuppertal	Wuppertal	Germany	42283