CClinicalTrials.gg
Not yet recruitingNCT07702760IMPLEMENT HFUpdated Jul 14, 2026

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

An observational study in HFrEF - Heart Failure With Reduced Ejection Fraction and Guideline Adherence, sponsored by Jasper Brugts MD PhD. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Jasper Brugts MD PhD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HFrEF - Heart Failure With Reduced Ejection Fraction
  • Guideline Adherence

Keywords

  • guideline recommended drug therapy
03

In context

Lead sponsor

This is the only study on the registry with Jasper Brugts MD PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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%.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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-up

Secondary 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 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07702760
Lead sponsor
Jasper Brugts MD PhD
Collaborators
Dutch Heart Foundation
Responsible party
Jasper Brugts MD PhD (Lead investigator of the CRO/Sponsor Erasmus MC, Department of Cardiology, Dr. Molewaterplein 40, Rotterdam, The Netherlands, Erasmus Medical Center) — Sponsor-investigator
First posted
Jul 14, 2026
Start date
Jul 7, 2026 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jul 14, 2026

Study contacts

Fleur Wildenbeest
Contact
f.wildenbeest@erasmusmc.nl
+31107040704
Rudolf de Boer, MD PhD
study chair · Erasmus Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion