Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06469645

The Role of SGLT2i in Management of Moderate AS

Led by University of East Anglia · Updated on 2024-06-21

104

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

U

University of East Anglia

Lead Sponsor

C

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Role of SGLT2i in Management of Moderate AS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate aortic stenosis defined by aortic valve peak velocity 23 3m/s or mean gradient 20-40mmHg, or aortic valve area 1.0-1.5cm2
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Severe aortic stenosis with aortic valve peak velocity 24 4m/s or mean gradient e 40mmHg or aortic valve area c 1.0cm2
  • Planned cardiac surgery or likely need for surgery within 6 months
  • Previous valve replacement
  • Severe hypertension with systolic e 180mmHg or diastolic e 100mmHg
  • Acute pulmonary oedema or cardiogenic shock
  • Other valvular lesions more than moderate severity
  • Hypertrophic cardiomyopathy or amyloidosis involving the heart
  • Contraindications to MRI including eGFR c 30ml/min/1.73m2
  • Pregnancy or breast-feeding
  • Current treatment with SGLT2 inhibitors
  • Inability to receive SGLT2 inhibitor therapy
  • History of type 1 or type 2 diabetes
  • Severe peripheral vascular disease or non-healed leg ulcers
  • Severe liver disease
  • Rare hereditary disorders such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption

AI-Screening

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Trial Site Locations

Total: 1 location

1

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Actively Recruiting

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Research Team

V

Vassilios S. Vassiliou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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