Active — Not RecruitingNot Applicable

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

Netherlands4,289 participantsStarted 2022-06-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained from subject aged ≥18 years.
✓. Diagnosis of heart failure according to the European Society of Cardiology 2021 guideline definitions. An eligible patient must also fulfil to the category definitions of de novo HF, chronic HF or worsening HF.
✓. Subjects willing and able to comply with the follow-up of regular care at the outpatient clinic. Also, sites should continue regular care for an included subject for at least 1 year (with preferably the entire project) at their outpatient HF clinic in this quality of care project.

Exclusion criteria

✕. Subjects with a life expectancy \<1 years due to comorbidities according to the treating physician.
✕. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke) within 2 months interacting with prescription or dosing of HF drugs.
✕. Subjects with advanced heart failure (end-stage) scheduled for or likely to undergo heart-transplantation or ventricular assist device within 6 months of baseline visit.

What they're measuring

Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF

Timeframe: anticipated follow-up is 5 years

Trial details

NCT IDNCT06386042

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-02

View on ClinicalTrials.gov More Heart Failure trials