Heart Failure
Conditions
Keywords
Heart Failure, SGLT-2 inhibitors, Digital implementation, Cardiorenal disease
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.
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.
Interventions
OTHERDigital 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.
Sponsors
Morten Schou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients initiating therapy with a SGLT-2 inhibitor | from randomisation up to 6 months |
Secondary
| 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 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORMorten Schou, MD, PhD
Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, Denmark
STUDY_CHAIRLars Køber, MD, DMSc
Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark
Outcome results
None listed