To Establish Whether Dapagliflozin and Spironolactone in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement, Result in Better Left Ventricular Mass Regression, Myocardial Health and Patient Reported Outcomes

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

About this trial

This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.

Even after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.

This study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.

There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.

Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.

These medicines might help patients after AVR by reducing heart muscle thickness and scarring.

Eligibility criteria

Qualifiers

Participants ≥ 18 years

LVEF ≥40%.

Diagnosed with severe symptomatic AS by the clinical care team.

Referred for surgical or transcatheter AVR (SAVR or TAVI).

Disqualifiers

Current use or intolerance or hypersensitivity to MRAs or SGLT2-inhibitors.

Hyperkalaemia (K>4.5 mmol/L)

Significant renal impairment (eGFR < 45 mL/min/1.73m²)

Severe hepatic insufficiency

Trial design

Treatments tested in this trial

  • Dapagliflozin (DAPA)
  • Spironolactone (drug)
  • Spironolactone + Dapagliflozin
  • Epleronone

Treatment groups

445 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators