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

Sponsor
University College, London
Study ID
NCT07539259
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (DAPA) — DRUG
    One tablet of Dapagliflozin once a day for the duration of the trial - 12 months (52 weeks).
  • Spironolactone (drug) — DRUG
    One tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
  • Spironolactone + Dapagliflozin — DRUG
    One tablet of Dapagliflozin and one tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
  • Epleronone — DRUG
    If a participant experiences significant side effects of Spironolactone they will be switched to Epleronone in line with clinical care.

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
445 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    One tablet of Dapagliflozin once a day for the duration of the trial - 12 months
  • Active Comparator: Spironolactone
    One tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
  • Active Comparator: Dapagliflozin and Spironolactone
    one tablet of Dapagliflozin and one tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
  • No Intervention: Standard of care
    Standard of care

Primary Outcome Measure

Change in the left ventricular mass indexed from pre Aortic Valve Replacement (AVR) to 12 months post AVR [ Time Frame: 12 months ]

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