Heart FailureEMAIL-HFNCT05890131
Implementation of SGLT-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
A study testing Digital letter in people with Heart Failure, run by Morten Schou at 5 sites in Denmark.
Trial summary
The implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. This prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Digital letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,996 participants
- Where
- 5 sitesDenmark
- Study dates
- 3 May 2023to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered diagnosis of heart failure within the last 10 years
- Living in the Capital Region of Denmark or Roskilde
- Age ≥20 years
Who cannot join
- Redeemed prescription of a SGLT-2 inhibitor after 2015
- Type 1 diabetes
- History of diabetic ketoacidosis
- Chronic kidney disease in long term dialysis
- Living in a nursing home
- Dementia
- Cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer)
- Exemption from the public digital mailbox system
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Bispebjerg-Frederiksberg Hospital
Copenhagen, 2400
Herlev and Gentofte University Hospital
Hellerup, 2900
Nordsjællands Hospital
Hillerød, 3400
Amager-Hvidovre-Glostrup Hospital
Hvidovre, 2650
Sjællands Universitetshospital - Roskilde
Roskilde, 4000
About this study
Official title: Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
The implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. This prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient associations.
The main objective of this clinical trial is to determine whether a new digital strategy that employs official digital letters to inform and invite patients to evaluate their eligibility for new therapies, specifically the sodium-glucose co-transporter-2 (SGLT-2) inhibitor for heart failure patients, can facilitate and optimise the implementation. The aim is to increase the number of eligible patients with heart failure who start taking SGLT-2 inhibitors and reduce the time it takes to initiate treatment compared to the current process. Ultimately, this approach may improve patient outcomes.
Read the detailed description
The study is a prospective, multicenter, two-armed, randomised clinical trial that will be coordinated from the Department of Cardiology, Herlev-Gentofte Hospital. The primary objective of the study is to determine whether a new digital strategy can be implemented to introduce novel medical therapies, specifically sodium-glucose co-transporter-2 (SGLT-2) inhibitors to heart failure patients. The aim is to increase the number of eligible patients who initiate therapy and to reduce the time taken to initiate therapy compared to the current process. The study will recruit patients with a registered diagnosis of heart failure residing in The Capital Region of Denmark and Roskilde, who have not yet been started on SGLT-2 inhibitor therapy. Patient identification and recruitment will be carried out through Danish nationwide registries, using their personal identification number (CPR-number), which is also linked to a secure digital mailbox where all official letters from public authorities are sent to Danish citizens. Patients will be randomly assigned (1:1) to receive a digital letter containing evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. Outcome measures will be obtained from Danish nationwide registers at pre-specified time points and in collaboration with the Danish Health Data Authority.
- Conditions
- Heart Failure
- Being tested
- Digital letter
- Keywords
- Heart Failure, SGLT-2 inhibitors, Digital implementation, Cardiorenal disease
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital letterOther
A digital letter with evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Digital letter | Experimental | The experimental group will receive a digital letter with information on the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. Receives: Other: Digital letter |
| Control | No intervention | The control group will not be sent the digital letter and will therefore receive usual follow-up and care in the public healthcare system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients initiating therapy with a SGLT-2 inhibitor
Measured: from randomisation up to 6 months
Secondary outcomes (1)
Time to first occurrence of a composite heart failure endpoint consisting of all-cause death or heart failure hospitalisation.
Measured: from randomisation up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start3 May 2023
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,996 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Schou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Schou, Herlev and Gentofte Hospital
- Investigators
- Morten Schou, MD, PhD, Principal investigator, Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, DenmarkLars Køber, MD, DMSc, Study chair, Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890131
- Sponsor's protocol ID
- P-2022-675
- Acronym
- EMAIL-HF
- Status last verified
- Jun 2025
- First submitted
- 3 May 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from nationwide administrative registers, that are stored and managed by the Danish Health Data Authority. Data access can only be made available to a third party through an affiliation to an authorized Danish research environment. Please contact the sponsor-investigator in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
- ClinicalTrials.gov ID
- NCT05890131
- Acronym / sponsor ID
- EMAIL-HF / P-2022-675
- Conditions
- Heart Failure
- Keywords
- Heart Failure, SGLT-2 inhibitors, Digital implementation, Cardiorenal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,996 participants (actual)
- Lead sponsor
- Morten SchouUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 6 Jun 2023 (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 implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. This prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient associations.
The main objective of this clinical trial is to determine whether a new digital strategy that employs official digital letters to inform and invite patients to evaluate their eligibility for new therapies, specifically the sodium-glucose co-transporter-2 (SGLT-2) inhibitor for heart failure patients, can facilitate and optimise the implementation. The aim is to increase the number of eligible patients with heart failure who start taking SGLT-2 inhibitors and reduce the time it takes to initiate treatment compared to the current process. Ultimately, this approach may improve patient outcomes.
Detailed description
The study is a prospective, multicenter, two-armed, randomised clinical trial that will be coordinated from the Department of Cardiology, Herlev-Gentofte Hospital. The primary objective of the study is to determine whether a new digital strategy can be implemented to introduce novel medical therapies, specifically sodium-glucose co-transporter-2 (SGLT-2) inhibitors to heart failure patients. The aim is to increase the number of eligible patients who initiate therapy and to reduce the time taken to initiate therapy compared to the current process. The study will recruit patients with a registered diagnosis of heart failure residing in The Capital Region of Denmark and Roskilde, who have not yet been started on SGLT-2 inhibitor therapy. Patient identification and recruitment will be carried out through Danish nationwide registries, using their personal identification number (CPR-number), which is also linked to a secure digital mailbox where all official letters from public authorities are sent to Danish citizens. Patients will be randomly assigned (1:1) to receive a digital letter containing evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. Outcome measures will be obtained from Danish nationwide registers at pre-specified time points and in collaboration with the Danish Health Data Authority.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital letter | Experimental | Other: Digital letterThe experimental group will receive a digital letter with information on the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. |
| Control | No intervention | –The control group will not be sent the digital letter and will therefore receive usual follow-up and care in the public healthcare system. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered diagnosis of heart failure within the last 10 years
- Living in the Capital Region of Denmark or Roskilde
- Age ≥20 years
Key exclusion criteria (8 listed)
- Redeemed prescription of a SGLT-2 inhibitor after 2015
- Type 1 diabetes
- History of diabetic ketoacidosis
- Chronic kidney disease in long term dialysis
- Living in a nursing home
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 |
|---|---|---|
| Digital letterA digital letter with evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. | Other | Digital letter |
Primary outcome
Proportion of patients initiating therapy with a SGLT-2 inhibitor
Time frame: from randomisation up to 6 months
1 secondary outcome
Time to first occurrence of a composite heart failure endpoint consisting of all-cause death or heart failure hospitalisation.
Time frame: from randomisation up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be collected from nationwide administrative registers, that are stored and managed by the Danish Health Data Authority. Data access can only be made available to a third party through an affiliation to an authorized Danish research environment. Please contact the sponsor-investigator in case of any inquiries.
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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.
Morten Schou, MD, PhD principal investigator
Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, Denmark
Lars Køber, MD, DMSc study chair
Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital letter in people with Heart Failure, run by Morten Schou at 5 sites in Denmark.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 13 Apr 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients initiating therapy with a SGLT-2 inhibitor (time frame: from randomisation up to 6 months). 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 Apr 2026.