Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
NCT05775354
Arrhythmias, Cardiac, Arterial Occlusive Diseases
Utrecht, Netherlands
View Trial DetailsNCT Number: NCT04844944
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Helios Klinikum Berlin-Buch, Berlin, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 3 days
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 3 days
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Contact information is provided by the study sponsor or research team.
Helios Health Institute GmbH
Other
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
Acronym: H²-Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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