Clinical trial NCT05890131: Implementation of SGLT-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
Official title: Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
SGLT-2 inhibitors
Digital implementation
Cardiorenal disease
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 5996
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients initiating therapy with a SGLT-2 inhibitor
timeFrame: from randomisation up to 6 months
Secondary outcomes:
measure: Time to first occurrence of a composite heart failure endpoint consisting of all-cause death or heart failure hospitalisation.
timeFrame: from randomisation up to 2 years
Other outcomes:
measure: Number of all-cause deaths and heart failure hospitalisations
timeFrame: from randomisation up to 2 years
measure: 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.
timeFrame: from randomisation up to 2 years
measure: 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.
timeFrame: from randomisation up to 2 years
measure: Time to initiation of SGLT-2 inhibitor therapy
timeFrame: from randomisation up to 2 years
measure: Adherence to SGLT-2 inhibitor therapy (defined as proportion of days covered >=80%)
timeFrame: from randomisation up to 1 year
measure: Proportion of elderly (>75 years) initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
measure: Proportion of patients with lower educational level initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
measure: Proportion of patients with lower socioeconomic level initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
measure: Proportion of immigrants initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
measure: Proportion of patients with type 2 diabetes initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
measure: Proportion of male and female patients initiating therapy with SGLT-2 inhibitors
timeFrame: from randomisation up to 2 years
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg-Frederiksberg Hospital
city: Hellerup
country: Denmark
facility: Herlev and Gentofte University Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Hvidovre
country: Denmark
facility: Amager-Hvidovre-Glostrup Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital - Roskilde
Study officials:
affiliation: Department of Cardiology, Herlev and Gentofte Hospital, 2900 Hellerup, Denmark
name: Morten Schou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark
name: Lars Køber, MD, DMSc
role: STUDY_CHAIR
References: