Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJasper Brugts MD PhD
About this trial
The IMPLEMENT HF study is part of the national heart failure quality of care registry (evaluation of given health care). Within the HF registry, the investigators will investigate whether mirror information on the actual 4 pillars of guideline directed medical therapy (GDMT) in HFrEF patients will help to further improve the implementation of GDMT.
Data will be used from the national HF registry in the Netherlands. Two groups will be studied, one where the HCP receives the mirror information on GDMT and one where both the patient and the HCP receive the mirror information on GDMT. GDMT or the 4 pillars treatment is standard of care as recommended by the ESC HF guidelines, indicated for all HFrEF patients. The project is a quality of care registry and health care evaluation to optimize adherence to the HF guidelines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age ≥18 years
Diagnosis of HFrEF according to ESC HF 2026 guidelines (EF <50%)
Participant is willing to participate for 1 years of follow-up for standard of care at the outpatient clinic of the participating hospital and the local investigator follows the patients for the time frame of 1 years on reported endpoints.
Disqualifiers
An expected life expectancy less than 1 year due to other comorbidities according to the treating physician
A major CV event (e.g. disabling stroke, open heart surgery) within 3 months of enrollment, if likely to interfere with GDMT titration or regular follow-up.
Advanced or Endstage Heart Failure stage in which advanced HF treatment with an LVAD or heart transplant is anticipated within 6 months after the baseline visit.
Trial population
Patients with de novo / newly diagnosed heart failure with reduced ejection fraction
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: Guideline recommended drug therapy for HFrEF with mirror information to HCP
Group B: Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient
Trial outcomes
Primary outcomes
1
The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients.
The prescription level (%) of GDMT / 4 pillars in patients with de novo HFrEF at specific time moments durign 1 year (6 weeks, 3 Months , 6 Months, 12 Months)
Time frame
1 year of follow-upSecondary outcomes
1
The % of target dose of GDMT prescribed in de novo HFrEF patients
The dosing level of a GDMT drug class as % of the guideline recommended dose during 1 year of follow-up.
Time frame
1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).2
Incident events
The incidence of all-cause mortality and HF hospitalisations during 12 months of follow-up (and the individual components of the composite outcome).
Time frame
1 year of follow-up (12 months)Other outcomes
1
GDMT adherence in subgroups of age (elderly) and sex (men/women)
GDMT adherence in subgroups of age (elderly) and sex (men/women)
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jasper Brugts MD PhD
Lead sponsor
Erasmus Medical Center
Sponsor institution
Dutch Heart Foundation
Collaborator
Source ClinicalTrials.gov