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

Heart Failure Clinical Trial

— TITRATE-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06386042
• Other study ID #: MEC-2022-0252
• Status: Active, not recruiting
• Start date: June 5, 2022
• Est. completion date: April 2029

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4289
• Est. completion date: April 2029
• Est. primary completion date: February 14, 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

In order to be eligible to participate in this registry, a subject must meet all of the

following criteria:

1. Written informed consent obtained from subject aged =18 years.

2. 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.

3. 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. 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:

1. Subjects with a life expectancy <1 years due to comorbidities according to the treating physician.

2. 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.

3. 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Netherlands Heart Institute

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Clephas PRD, Malgie J, Schaap J, Koudstaal S, Emans M, Linssen GCM, de Boer GA, van Heerebeek L, Borleffs CJW, Manintveld OC, van Empel V, van Wijk S, van den Heuvel M, da Fonseca C, Damman K, van Ramshorst J, van Kimmenade R, van de Ven ART, Tio RA, van Veghel D, Asselbergs FW, de Boer RA, van der Meer P, Greene SJ, Brunner-La Rocca HP, Brugts JJ. Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE-HF. ESC Heart Fail. 2024 Feb;11(1):550-559. doi: 10.1002/ehf2.14604. Epub 2023 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF	according to European Society of Cardiology guideline recommendations	anticipated follow-up is 5 years
Secondary	All-cause mortality	Death	anticipated follow-up is 5 years
Secondary	Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv.	Hospitalisation	anticipated follow-up is 5 years
Secondary	Hospital admission due to non heart failure related event	Hospitalisation	anticipated follow-up is 5 years