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

NCT05890131 | Completed

• 1 other identifier: P-2022-675
• Study Type: interventional
• Target: 5,996
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Heart Failure

Keywords

Heart Failure; SGLT-2 inhibitors; Digital implementation; Cardiorenal disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients initiating therapy with a SGLT-2 inhibitor

  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.

  from randomisation up to 2 years

Other Outcomes (11)

• 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

Study Arms (2)

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.

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.

Interventions

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.

Digital letter

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morten Schou: lead

Study Sites (5)

Bispebjerg-Frederiksberg Hospital

Copenhagen, 2400, Denmark

Location

Herlev and Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Amager-Hvidovre-Glostrup Hospital

Hvidovre, 2650, Denmark

Location

Sjællands Universitetshospital - Roskilde

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Morten Schou, MD, PhD

  Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, Denmark

  PRINCIPAL INVESTIGATOR

• Lars Køber, MD, DMSc

  Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the trial design, blinding the patients who received the digital letters is not possible. However, the letters do not disclose that they were sent as part of a randomized trial, which enhances the generalizability of the study intervention. Additionally, patients in the control group, who did not receive a letter, remain unaware that they are part of the control group in a randomized trial. Also, the HF specialists who prescribed the SGLT2 inhibitors are blinded to the primary endpoint, as they do not receive information on whether patients actually redeemed their prescriptions and commenced the medication.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 6, 2023
• Study Start: May 3, 2023
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (5)