The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
- Conditions
- Heart FailureAtrial FibrillationCoronary Artery Disease
- Registration Number
- NCT04844944
- Lead Sponsor
- Helios Health Institute GmbH
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24000
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality during f/u 18 months
- Secondary Outcome Measures
Name Time Method general quality of life (PROMIS) 18 months general quality of life (PHQ2) 18 months rate of rehospitalizations for cardiovascular causes during f/u 18 months cardiovascular mortality during f/u 18 months length of hospital stay 3 days disease specific quality of life (KCCQ-12 [HF]) 18 months disease specific quality of life (SAQ-7 [CAD]) 18 months rate of rehospitalizations of any cause during f/u 18 months disease specific quality of life (AFEQT [AF]) 18 months 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.
in-hospital mortality 3 days rate of rehospitalizations for specific cardiovascular diseases 18 months rate of specific cardiovascular events 18 months 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.
disease associated treatment costs 18 months 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.
Trial Locations
- Locations (10)
Helios Dr. Horst Schmidt Kliniken Wiesbaden
🇩🇪Wiesbaden, Germany
Heart Center Leipzig at University of Leipzig
🇩🇪Leipzig, Germany
Helios Universitätsklinikum Wuppertal
🇩🇪Wuppertal, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Helios Klinikum Siegburg
🇩🇪Siegburg, Germany
Helios Klinikum Schwerin
🇩🇪Schwerin, Germany
Helios Klinikum Gifhorn
🇩🇪Gifhorn, Germany
Helios Klinikum Hildesheim
🇩🇪Hildesheim, Germany
Helios Vogtlandklinikum Plauen
🇩🇪Plauen, Germany