Heart FailureADMINISTER IINCT06844006
Investigating the Impact of Nudging Cardiologists to Prescribe Class I Recommendations Foundational- and Additional Medical Therapy in Heart Failure Patients
A study testing Nudging in people with Heart Failure, run by Medisch Spectrum Twente at 5 sites in Netherlands.
Trial summary
This study investigates the impact of a nudge-based intervention on improving 2026 European Society of Cardiology guideline class I Foundational Medical Therapy (FMT) and Additional medical therapy (AMT) prescription among cardiologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Nudging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 5 sitesNetherlands
- Study dates
- 9 Oct 2026to 9 Jul 2028
- Phase
- Interventional
- 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
Who may be able to join
- All heart failure diagnoses
- >18 years
Who cannot join
- Not understanding the Dutch Language.
- Allergies that make uptitration impossible.
- Admission to hospice or palliative care.
- Severe psychological disorders.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
OLVG-oost
Amsterdam, North Holland, 1091AC
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
St. Antonius hospital
Nieuwegein, Utrecht, 3435CM
Maasstad hospital
Rotterdam, South Holland, 3079DZ
About this study
Official title: Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial
This study investigates the impact of a nudge-based intervention on improving 2026 European Society of Cardiology guideline class I Foundational Medical Therapy (FMT) and Additional medical therapy (AMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.
- Conditions
- Heart Failure
- Being tested
- Nudging
- Keywords
- Digitial Care, Home monitoring, Heart Failure, Nudging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgingCombination product
Clinicians will be nudged with a prompt, including remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to class I 2026 ESC recommendations of FMT and AMT is possible.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care. Receives: Combination Product: Nudging |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF related hospitalization
The frequency of HF related hospitalization and duration of the hospitalization.
Measured: HF related hospitalization during the 15 month duration of the study.
All cause death
Measured: All cause death rate during the 15 month duration of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start9 Oct 2026
- Primary completion9 Jan 2028 (estimated)
- Study completion9 Jul 2028 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stepped Wedge Randomized Controlled Trial.
- Masking
- None (open label)
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, St. Antonius Hospital, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
- Responsible party
- Principal investigator, Mark Schuuring, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844006
- Sponsor's protocol ID
- ADMINISTER II
- Acronym
- ADMINISTER II
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
PubMed 39217271
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial
- ClinicalTrials.gov ID
- NCT06844006
- Acronym / sponsor ID
- ADMINISTER II / ADMINISTER II
- Conditions
- Heart Failure
- Keywords
- Digitial Care, Home monitoring, Heart Failure, Nudging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, St. Antonius Hospital, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 9 Jul 2028 (estimated)
- First posted
- 25 Feb 2025 (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.
This study investigates the impact of a nudge-based intervention on improving 2026 European Society of Cardiology guideline class I Foundational Medical Therapy (FMT) and Additional medical therapy (AMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped Wedge Randomized Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Combination Product: NudgingAll cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All heart failure diagnoses
- >18 years
Key exclusion criteria (4 listed)
- Not understanding the Dutch Language.
- Allergies that make uptitration impossible.
- Admission to hospice or palliative care.
- Severe psychological disorders.
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 |
|---|---|---|
| NudgingClinicians will be nudged with a prompt, including remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to class I 2026 ESC recommendations of FMT and AMT is possible. | Combination product | Intervention |
Primary outcome
HF related hospitalization
Time frame: HF related hospitalization during the 15 month duration of the study.
The frequency of HF related hospitalization and duration of the hospitalization.
All cause death
Time frame: All cause death rate during the 15 month duration of the study.
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 Oct 2026.
- Results publication: PubMed 39217271Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudging in people with Heart Failure, run by Medisch Spectrum Twente at 5 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 15 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 5 sites 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?
HF related hospitalization (time frame: HF related hospitalization during the 15 month duration of the study.). The study lists 2 primary outcomes in all. 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 NCT06844006, 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 Oct 2026.