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NCT06386042Recruitment Completed

Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry

Erasmus Medical CenterClinicalTrials.govother
Study focus
Disease/Condition
Heart Failure
Drug/Device/Intervention
no intervention, observational study
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Erasmus Medical Center
Location
Rotterdam, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Jun 05, 2022
End date
Apr 01, 2029
Enrollment
4289 participants
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
Heart failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureLeft ventricular failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06386042
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.