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NCT Number: NCT05890131

Implementation of 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Registered diagnosis of heart failure within the last 10 years
  • Living in the Capital Region of Denmark or Roskilde
  • Age ≥20 years

Exclusion criteria

  • 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

Treatment and study plan

Digital letter

Other

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.

Primary outcomes

  1. Proportion of patients initiating therapy with a SGLT-2 inhibitor

    Time frame: 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.

    Time frame: from randomisation up to 2 years

Other outcomes

  1. Number of all-cause deaths and heart failure hospitalisations

    Time frame: from randomisation up to 2 years

  2. Time to first occurrence of a 3-point expanded composite heart failure endpoint consisting of all-cause death, heart failure hospitalisation, or renal failure, with examination of the components of this composite.

    Time frame: from randomisation up to 2 years

  3. Time to first occurrence of a 4-point expanded composite heart failure endpoint consisting of all-cause death, heart failure hospitalisation, non-fatal myocardial infarction, non-fatal stroke, with examination of the components of this composite.

    Time frame: from randomisation up to 2 years

  4. Time to initiation of SGLT-2 inhibitor therapy

    Time frame: from randomisation up to 2 years

  5. Adherence to SGLT-2 inhibitor therapy (defined as proportion of days covered >=80%)

    Time frame: from randomisation up to 1 year

  6. Proportion of elderly (>75 years) initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

  7. Proportion of patients with lower educational level initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

  8. Proportion of patients with lower socioeconomic level initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

  9. Proportion of immigrants initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

  10. Proportion of patients with type 2 diabetes initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

  11. Proportion of male and female patients initiating therapy with SGLT-2 inhibitors

    Time frame: from randomisation up to 2 years

Sponsors and collaborators

Lead sponsor

Morten Schou

Other

Registry information

Official study title

Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy

Acronym: EMAIL-HF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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