Heart FailureTITRATE-HFNCT06386042
Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry
An observational study of Heart Failure, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice. Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Injection or infusion
- How many people
- 4,289 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jun 2022to Apr 2029
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: The current registry studies only patient with heart failure and an ejection fraction below 50%. Type of heart failure patients * Chronic heart failure * Worsening heart failure * De novo or newly-diagnosed heart failure
Who may be able to join
- In order to be eligible to participate in this registry, a subject must meet all of the following criteria:
- Written informed consent obtained from subject aged ≥18 years.
- Diagnosis of heart failure according to the European Society of Cardiology 2021 guideline definitions. An eligible patient must also fulfil to the category definitions of de novo HF, chronic HF or worsening HF.
- Subjects willing and able to comply with the follow-up of regular care at the outpatient clinic. Also, sites should continue regular care for an included subject for at least 1 year (with preferably the entire project) at their outpatient HF clinic in this quality of care project.
- Informed Consent: As the current research is a patient file study (registry) without an intervention of any kind. The medical ethics review board has reviewed the study and the study is declared to be not subject to the Medical Research Involving Human Subjects Act. Although informed consent is not strictly necessary, we have decided to ask permission from the patient use to their data for scientific research and comply to privacy/general data protection regulations for scientific research as well as to consent with data-coupling with other official data sources for quality of care projects in the Netherlands.
Who cannot join
- Subjects with a life expectancy <1 years due to comorbidities according to the treating physician.
- Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke) within 2 months interacting with prescription or dosing of HF drugs.
- Subjects with advanced heart failure (end-stage) scheduled for or likely to undergo heart-transplantation or ventricular assist device within 6 months of baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.
Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).
Read more
Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).
Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.
Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.
Data: aggregated data
Intervention: none / no
Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure.
- Conditions
- Heart Failure
- Being tested
- no intervention, observational study
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observational studyOther
no intervention, observational registry of the prescription of medical therapy according to the European Society of Cardiology Heart Failure guidelines (quality of care).
| Study group | Role | What they receive |
|---|---|---|
| Chronic heart failure | Patients with chronic HF at least 6 months after the initial HF diagnosis with are in stable condition, treated with HF medication (not necessarily all GDMT) and evaluated for an intrinsic cardiac defibrillator device if applicable. Receives: Other: no intervention, observational study | |
| Worsening heart failure | Patient with established chronic heart failure which after a period of "stable" HF have experienced an hospital admission with necessity of iv. diuretics or urgent visit needing iv. diuretics. Patients can be included in inpatient / admitted setting or outpatient setting where drug changes during admission (GDMT uptitration) can be recorded. The index event of hospitalisation must be within 6 months prior to inclusion in the registry (retrospective). Receives: Other: no intervention, observational study | |
| de novo heart failure | Patients with heart failure with reduced ejection fraction (ejection fraction <40% with diagnosis within 3 months of inclusion (de novo heart failure or newly-diagnosed HF) with no previous diagnosis of HF. Receives: Other: no intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF
according to European Society of Cardiology guideline recommendations
Measured: anticipated follow-up is 5 years
Secondary outcomes (3)
All-cause mortality
Death
Measured: anticipated follow-up is 5 years
Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv.
Hospitalisation
Measured: anticipated follow-up is 5 years
Hospital admission due to non heart failure related event
Hospitalisation
Measured: anticipated follow-up is 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Jun 2022
- Primary completionFeb 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 4,289 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Institute
- Responsible party
- Principal investigator, Jasper Brugts MD PhD, Erasmus Medical Center
- Investigators
- Rudolf de Boer, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386042
- Sponsor's protocol ID
- MEC-2022-0252
- Acronym
- TITRATE-HF
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clephas PRD, Malgie J, Schaap J, Koudstaal S, Emans M, Linssen GCM, de Boer GA, van Heerebeek L, Borleffs CJW, Manintveld OC, van Empel V, van Wijk S, van den Heuvel M, da Fonseca C, Damman K, van Ramshorst J, van Kimmenade R, van de Ven ART, Tio RA, van Veghel D, Asselbergs FW, de Boer RA, van der Meer P, Greene SJ, Brunner-La Rocca HP, Brugts JJ. Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE-HF. ESC Heart Fail. 2024 Feb;11(1):550-559. doi: 10.1002/ehf2.14604. Epub 2023 Dec 8.
PubMed 38064176
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry
- ClinicalTrials.gov ID
- NCT06386042
- Acronym / sponsor ID
- TITRATE-HF / MEC-2022-0252
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,289 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Heart Institute
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 26 Apr 2024 (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.
SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.
Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).
Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).
Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.
Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.
Data: aggregated data
Intervention: none / no
Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic heart failure | – | Other: no intervention, observational studyPatients with chronic HF at least 6 months after the initial HF diagnosis with are in stable condition, treated with HF medication (not necessarily all GDMT) and evaluated for an intrinsic cardiac defibrillator device if applicable. |
| Worsening heart failure | – | Other: no intervention, observational studyPatient with established chronic heart failure which after a period of "stable" HF have experienced an hospital admission with necessity of iv. diuretics or urgent visit needing iv. diuretics. Patients can be included in inpatient / admitted setting or outpatient setting where drug changes during admission (GDMT uptitration) can be recorded. The index event of hospitalisation must be within 6 months prior to inclusion in the registry (retrospective). |
| de novo heart failure | – | Other: no intervention, observational studyPatients with heart failure with reduced ejection fraction (ejection fraction <40% with diagnosis within 3 months of inclusion (de novo heart failure or newly-diagnosed HF) with no previous diagnosis of HF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The current registry studies only patient with heart failure and an ejection fraction below 50%. Type of heart failure patients * Chronic heart failure * Worsening heart failure * De novo or newly-diagnosed heart failure
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this registry, a subject must meet all of the following criteria:
- Written informed consent obtained from subject aged ≥18 years.
- Diagnosis of heart failure according to the European Society of Cardiology 2021 guideline definitions. An eligible patient must also fulfil to the category definitions of de novo HF, chronic HF or worsening HF.
- Subjects willing and able to comply with the follow-up of regular care at the outpatient clinic. Also, sites should continue regular care for an included subject for at least 1 year (with preferably the entire project) at their outpatient HF clinic in this quality of care project.
- Informed Consent: As the current research is a patient file study (registry) without an intervention of any kind. The medical ethics review board has reviewed the study and the study is declared to be not subject to the Medical Research Involving Human Subjects Act. Although informed consent is not strictly necessary, we have decided to ask permission from the patient use to their data for scientific research and comply to privacy/general data protection regulations for scientific research as well as to consent with data-coupling with other official data sources for quality of care projects in the Netherlands.
Key exclusion criteria (3 listed)
- Subjects with a life expectancy <1 years due to comorbidities according to the treating physician.
- Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke) within 2 months interacting with prescription or dosing of HF drugs.
- Subjects with advanced heart failure (end-stage) scheduled for or likely to undergo heart-transplantation or ventricular assist device within 6 months of baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, observational studyno intervention, observational registry of the prescription of medical therapy according to the European Society of Cardiology Heart Failure guidelines (quality of care). | Other | Chronic heart failure, Worsening heart failure, de novo heart failure |
Primary outcome
Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF
Time frame: anticipated follow-up is 5 years
according to European Society of Cardiology guideline recommendations
3 secondary outcomes
All-cause mortality
Time frame: anticipated follow-up is 5 years
Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv.
Time frame: anticipated follow-up is 5 years
Hospital admission due to non heart failure related event
Time frame: anticipated follow-up is 5 years
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 15 Aug 2025.
- Background: PubMed 38064176Clephas PRD, Malgie J, Schaap J, Koudstaal S, Emans M, Linssen GCM, de Boer GA, van Heerebeek L, Borleffs CJW, Manintveld OC, van Empel V, van Wijk S, van den Heuvel M, da Fonseca C, Damman K, van Ramshorst J, van Kimmenade R, van de Ven ART, Tio RA, van Veghel D, Asselbergs FW, de Boer RA, van der Meer P, Greene SJ, Brunner-La Rocca HP, Brugts JJ. Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE-HF. ESC Heart Fail. 2024 Feb;11(1):550-559. doi: 10.1002/ehf2.14604. Epub 2023 Dec 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rudolf de Boer 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 Heart Failure, run by Erasmus Medical Center 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF (time frame: anticipated follow-up is 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386042, which also lists 1 linked publication.
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 15 Aug 2025.