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

NCT06386042 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4289

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

no intervention, observational study

no intervention, observational registry of the prescription of medical therapy according to the European Society of Cardiology Heart Failure guidelines (quality of care).

Sponsors & Collaborators

Principal Investigators

  • Rudolf de Boer · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-05
Primary Completion
2029-02-28
Completion
2029-04-30

Countries

  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386042 on ClinicalTrials.gov