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

Heart Failure Clinical Trial

— EMAIL-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890131
• Other study ID #: P-2022-675
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: January 2027

Study information

• Verified date: June 2023
• Source: Herlev and Gentofte Hospital
• Contact: Morten Schou, MD, PhD
• Phone: 0045 38683677
• Email: morten.schou.04[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Denmark	Bispebjerg-Frederiksberg Hospital	Copenhagen
Denmark	Herlev and Gentofte University Hospital	Hellerup
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Amager-Hvidovre-Glostrup Hospital	Hvidovre
Denmark	Sjællands Universitetshospital - Roskilde	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Morten Schou

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of all-cause deaths and heart failure hospitalisations		from randomisation up to 2 years
Other	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
Other	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
Other	Time to initiation of SGLT-2 inhibitor therapy		from randomisation up to 2 years
Other	Adherence to SGLT-2 inhibitor therapy (defined as proportion of days covered >=80%)		from randomisation up to 1 year
Other	Proportion of elderly (>75 years) initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Other	Proportion of patients with lower educational level initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Other	Proportion of patients with lower socioeconomic level initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Other	Proportion of immigrants initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Other	Proportion of patients with type 2 diabetes initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Other	Proportion of male and female patients initiating therapy with SGLT-2 inhibitors		from randomisation up to 2 years
Primary	Proportion of patients initiating therapy with a SGLT-2 inhibitor		from randomisation up to 6 months
Secondary	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