Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) (IMPLEMENT HF)

Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF): The IMPLEMENT-HF Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Guideline Adherence; HFrEF - Heart Failure With Reduced Ejection Fraction

Detailed Description

The IMPLEMENT HF is a sequel study to the TITRATE HF study that has shown that the level of GDMT prescription in de novo HFrEF can be further improved. The investigators hypothesize that mirror information about actual levels of GDMT helps the physician and patient optimize GDMT as recommended in the guideline. The IMPLEMENT is a registry based study in 1500 with de novo HFrEF patients, in which mirror information on GDMT (4 pillars) prescription levels will be shown to the treating physician. In a second group (50%) both the physician and patient will receive the mirror information on the prescription of GDMT. For diversity, the investigators aim to include 50% elderly and 50% women in to the registry. The primary endpoint is the prescription level of GDMT. Secondary endpoints are the dosing levels of GDMT (% target dose) and incident clinical events.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Fleur Wildenbeest; Phone Number: +31107040704; Email: f.wildenbeest@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with de novo / newly diagnosed heart failure with reduced ejection fraction

Description

Inclusion Criteria:

1. Written informed consent
2. Age ≥18 years
3. Diagnosis of HFrEF according to ESC HF guidelines (EF <40%)
4. 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.

Exclusion Criteria:

1. An expected life expectancy less than 1 year due to other comorbidities according to the treating physician
2. A major CV event (e.g. disabling stroke, myocardial infarction, open heart surgery) within 3 months of enrollment, if likely to interfere with GDMT titration or regular follow-up.
3. 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.

At enrollment the patient has heart failure with reduction ejection fraction with an established EF below 40%.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Guideline recommended drug therapy for HFrEF with mirror information to HCP
Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient; Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).
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).	1 year of follow-up (12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GDMT adherence in subgroups of age (elderly) and sex (men/women)	GDMT adherence in subgroups of age (elderly) and sex (men/women)	12 months

Collaborators and Investigators

• Sponsor: Jasper Brugts MD PhD
• Collaborators: Dutch Heart Foundation
• Investigators: Study Chair: Rudolf de Boer, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 7, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: guideline recommended drug therapy
• Other Study ID Numbers: MEC-2025-0356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The project is part of the NHR HF registry and follow the protocols and rules of the NHR on IPD accordingly (including GDPR/AVG), when applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No