Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry - Trial NCT06386042
Access comprehensive clinical trial information for NCT06386042 through Pure Global AI's free database. This phase not specified trial is sponsored by Erasmus Medical Center and is currently Recruitment Completed. The study focuses on Heart Failure. Target enrollment is 4289 participants.
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Study Focus
Sponsor & Location
Erasmus Medical Center
Timeline & Enrollment
N/A
Jun 05, 2022
Apr 01, 2029
Primary Outcome
Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06386042
Non-Device Trial