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

NCT07702760 | Not Yet Recruiting DMC

• 1 other identifier: MEC-2025-0356
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction; Guideline Adherence

Keywords

guideline recommended drug therapy

Outcome Measures

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)

  1 year of follow-up

Secondary Outcomes (2)

• The % of target dose of GDMT prescribed in de novo HFrEF patients

  1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).

• Incident events

  1 year of follow-up (12 months)

Other Outcomes (1)

• GDMT adherence in subgroups of age (elderly) and sex (men/women)

  12 months

Study Arms (2)

Guideline recommended drug therapy for HFrEF with mirror information to HCP

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Written informed consent
• Age ≥18 years
• Diagnosis of HFrEF according to ESC HF guidelines (EF \<40%)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jasper Brugts MD PhD: lead
• Dutch Heart Foundation: collaborator

Study Officials

• Rudolf de Boer, MD PhD

  Erasmus Medical Center

  STUDY CHAIR

Central Study Contacts

Fleur Wildenbeest

CONTACT

+31107040704; f.wildenbeest@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead investigator of the CRO/Sponsor Erasmus MC, Department of Cardiology, Dr. Molewaterplein 40, Rotterdam, The Netherlands

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-06