Implementation of SGLT-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy (EMAIL-HF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Digital letter

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 Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morten Schou, MD, PhD; Phone Number: 0045 38683677; Email: morten.schou.04@regionh.dk
• Study Contact Backup: Name: Mariam E Malik, MD; Email: mariam.elmegaard.malik@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Recruiting
    • Bispebjerg-Frederiksberg Hospital
    • Contact: Jens J Thune, MD, PhD
    • Sub-Investigator: Jens J Thune, MD, PhD
    • Sub-Investigator: Christian D Tuxen, MD, PhD
  • Hellerup, Denmark, 2900
    • Recruiting
    • Herlev and Gentofte University Hospital
    • Contact: Morten Schou, MD, PhD, Prof.
    • Sub-Investigator: Morten Schou, MD, PhD, Prof.
    • Sub-Investigator: Trine K Lauridsen, MD, PhD
  • Hillerød, Denmark, 3400
    • Recruiting
    • Nordsjællands Hospital
    • Contact: Nis O Stride, MD, PhD
    • Sub-Investigator: Nis O Stride, MD, PhD
    • Sub-Investigator: Emil Wolsk, MD, PhD
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Amager-Hvidovre-Glostrup Hospital
    • Contact: Morten Petersen, MD, PhD
    • Sub-Investigator: Morten Petersen, MD, PhD
    • Sub-Investigator: Anders Barasa, MD, PhD
    • Sub-Investigator: Mads K Ersbøl, MD, PhD
  • Roskilde, Denmark, 4000
    • Recruiting
    • Sjællands Universitetshospital - Roskilde
    • Contact: Nadia Dridi, MD, PhD
    • Sub-Investigator: Nadia Dridi, MD, PhD
    • Sub-Investigator: Lars Køber, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Redeemed prescription of a SGLT-2 inhibitor after 2015
2. Type 1 diabetes
3. History of diabetic ketoacidosis
4. Chronic kidney disease in long term dialysis
5. Living in a nursing home
6. Dementia
7. Cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer)
8. Exemption from the public digital mailbox system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital letter; 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.	Other: Digital letter; 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.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients initiating therapy with a SGLT-2 inhibitor	from randomisation up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of a composite heart failure endpoint consisting of all-cause death or heart failure hospitalisation.	from randomisation up to 2 years

Other Outcome Measures

Outcome Measure	Time Frame
Number of all-cause deaths and heart failure hospitalisations	from randomisation up to 2 years
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.	from randomisation up to 2 years
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.	from randomisation up to 2 years
Time to initiation of SGLT-2 inhibitor therapy	from randomisation up to 2 years
Adherence to SGLT-2 inhibitor therapy (defined as proportion of days covered >=80%)	from randomisation up to 1 year
Proportion of elderly (>75 years) initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years
Proportion of patients with lower educational level initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years
Proportion of patients with lower socioeconomic level initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years
Proportion of immigrants initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years
Proportion of patients with type 2 diabetes initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years
Proportion of male and female patients initiating therapy with SGLT-2 inhibitors	from randomisation up to 2 years

Collaborators and Investigators

• Sponsor: Morten Schou
• Investigators: Principal Investigator: Morten Schou, MD, PhD, Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, Denmark; Study Chair: Lars Køber, MD, DMSc, Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; SGLT-2 inhibitors; Digital implementation; Cardiorenal disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P-2022-675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No