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.
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 Type
OBSERVATIONAL
Enrollment
24,000
Helios Klinikum Berlin-Buch
Berlin, Germany
ACTIVE_NOT_RECRUITINGHelios Klinikum Erfurt
Erfurt, Germany
ACTIVE_NOT_RECRUITINGHelios Klinikum Gifhorn
Gifhorn, Germany
All-cause mortality during f/u
Time frame: 6 months
All-cause mortality during f/u
Time frame: 12 months
All-cause mortality during f/u
Time frame: 18 months
in-hospital mortality
Time frame: 3 days
cardiovascular mortality during f/u
Time frame: 6 months
cardiovascular mortality during f/u
Time frame: 12 months
cardiovascular mortality during f/u
Time frame: 18 months
length of hospital stay
Time frame: 3 days
rate of rehospitalizations of any cause during f/u
Time frame: 6 months
rate of rehospitalizations of any cause during f/u
Time frame: 12 months
rate of rehospitalizations of any cause during f/u
Time frame: 18 months
rate of rehospitalizations for cardiovascular causes during f/u
Time frame: 6 months
rate of rehospitalizations for cardiovascular causes during f/u
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Helios Klinikum Hildesheim
Hildesheim, Germany
RECRUITINGHeart Center Leipzig at University of Leipzig
Leipzig, Germany
ACTIVE_NOT_RECRUITINGHelios Vogtlandklinikum Plauen
Plauen, Germany
ACTIVE_NOT_RECRUITINGHelios Klinikum Schwerin
Schwerin, Germany
RECRUITINGHelios Klinikum Siegburg
Siegburg, Germany
ACTIVE_NOT_RECRUITINGHelios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany
RECRUITINGHelios Universitätsklinikum Wuppertal
Wuppertal, Germany
RECRUITINGTime frame: 12 months
rate of rehospitalizations for cardiovascular causes during f/u
Time frame: 18 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 6 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 12 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 18 months
rate of specific cardiovascular events
Time frame: 6 months
rate of specific cardiovascular events
Time frame: 12 months
rate of specific cardiovascular events
Time frame: 18 months
general quality of life (PROMIS)
Time frame: 6 months
general quality of life (PROMIS)
Time frame: 12 months
general quality of life (PROMIS)
Time frame: 18 months
general quality of life (PHQ2)
Time frame: 6 months
general quality of life (PHQ2)
Time frame: 12 months
general quality of life (PHQ2)
Time frame: 18 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 6 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 12 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 18 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 6 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 12 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 18 months
disease specific quality of life (AFEQT [AF])
Time frame: 6 months
disease specific quality of life (AFEQT [AF])
Time frame: 12 months
disease specific quality of life (AFEQT [AF])
Time frame: 18 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 18 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 18 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 18 months
disease associated treatment costs
Time frame: 6 months
disease associated treatment costs
Time frame: 12 months
disease associated treatment costs
Time frame: 18 months