HFrEF - Heart Failure With Reduced Ejection FractionIMPLEMENT HFNCT07702760
Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and Guideline Adherence, run by Jasper Brugts MD PhD at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, Guideline Adherence
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jul 2026to 1 Dec 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo / newly diagnosed heart failure with reduced ejection fraction
Who may be able to join
- 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.
Who cannot join
- 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.
- At enrollment the patient has an established diagnosis of heart failure with reduction ejection fraction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Centre
Rotterdam
Fleur Wildebeest, 0031107040704, f.wildebeest@erasmusmc.nl
About this study
Official title: 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.
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.
- Keywords
- guideline recommended drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year of follow-up
Secondary outcomes (2)
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.
Measured: 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).
Measured: 1 year of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start7 Jul 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jasper Brugts MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Sponsor-investigator, Jasper Brugts MD PhD, Erasmus Medical Center
- Investigators
- Rudolf de Boer, MD PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702760
- Sponsor's protocol ID
- MEC-2025-0356
- Acronym
- IMPLEMENT HF
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF): The IMPLEMENT-HF Study.
- ClinicalTrials.gov ID
- NCT07702760
- Acronym / sponsor ID
- IMPLEMENT HF / MEC-2025-0356
- Keywords
- guideline recommended drug therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Jasper Brugts MD PhDUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo / newly diagnosed heart failure with reduced ejection fraction
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- At enrollment the patient has an established diagnosis of heart failure with reduction ejection fraction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients.
Time frame: 1 year of follow-up
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)
2 secondary outcomes
The % of target dose of GDMT prescribed in de novo HFrEF patients
Time frame: 1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).
Incident events
Time frame: 1 year of follow-up (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf de Boer, MD PhD study chair
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and Guideline Adherence, run by Jasper Brugts MD PhD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fleur Wildenbeest (+31107040704, f.wildenbeest@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients. (time frame: 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.