Erasmus MC
Rotterdam, South Holland, 3015CE, Netherlands
NCT Number: NCT06386042
SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.
Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).
Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).
Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.
Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.
Data: aggregated data
Intervention: none / no
Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Rotterdam, South Holland, 3015CE, Netherlands
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this registry, a subject must meet all of the following criteria:
Informed Consent: As the current research is a patient file study (registry) without an intervention of any kind. The medical ethics review board has reviewed the study and the study is declared to be not subject to the Medical Research Involving Human Subjects Act. Although informed consent is not strictly necessary, we have decided to ask permission from the patient use to their data for scientific research and comply to privacy/general data protection regulations for scientific research as well as to consent with data-coupling with other official data sources for quality of care projects in the Netherlands.
Exclusion criteria
no intervention, observational registry of the prescription of medical therapy according to the European Society of Cardiology Heart Failure guidelines (quality of care).
Time frame: anticipated follow-up is 5 years
according to European Society of Cardiology guideline recommendations
Time frame: anticipated follow-up is 5 years
Death
Time frame: anticipated follow-up is 5 years
Hospitalisation
Time frame: anticipated follow-up is 5 years
Hospitalisation
Erasmus Medical Center
Other
Acronym: TITRATE-HF
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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