The Role of Sodium Glucose Cotransporter 2 Inhibitors in the Management of Patients With Aortic Stenosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Background: The aortic valve is like a door in the heart that lets blood flow out to the body. Over time, this valve can get worn out and become too narrow, leading to a condition called aortic stenosis. When this happens, the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs. This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis. For people with aortic stenosis, this can lead to more problems like feeling out of breath, chest pain, and even needing to go to the hospital. It also increases the risk of dying from heart issues. There is a type of medication called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with weak heart muscle. These medicines were found to help the heart work better and improve the pumping of blood around the body. This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage. Aim of research study: The aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis. Using advanced imaging techniques (such as echocardiography and cardiovascular magnetic resonance), we intend to study their effect on the heart muscle of patients with aortic stenosis. Study design: Patients with moderate aortic stenosis will be invited for participation. Eligible consenting patients will have a baseline assessment with cardiac MRI scan, echocardiography, cardiopulmonary exercise test and validated quality of life questionnaires. They will then be randomised to receive either the SGLT2i for 6 months, or standard of care. All patients will undergo the same tests at 6 months. This way, we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Moderate aortic stenosis (aortic valve peak velocity ≥ 3m/s or mean gradient 20-40mmHg, or Aortic valve area 1.0-1.5cm2)

• Age over 18 years

Locations
Other Locations
United Kingdom
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Contact Information
Primary
Vassilios S. Vassiliou, PhD
v.vassiliou@uea.ac.uk
01603592534
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2026-02
Participants
Target number of participants: 104
Treatments
Experimental: Intervention Group
Patients randomised in this group will be taking the SLGT2 inhibitor (empagliflozin) on top of their regular medications for 6 months.
No_intervention: Control Group
Patients randomised in this group will continue to have their guideline directed conservative management with no changes in their regular medications.
Related Therapeutic Areas
Sponsors
Leads: University of East Anglia
Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

This content was sourced from clinicaltrials.gov