MedTrace Logo

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

NCT07539259 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Stenosis

Interventions

DRUG

Dapagliflozin (DAPA)

One tablet of Dapagliflozin once a day for the duration of the trial - 12 months (52 weeks).

DRUG

Spironolactone (drug)

One tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).

DRUG

Spironolactone + Dapagliflozin

One tablet of Dapagliflozin and one tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).

DRUG

Epleronone

If a participant experiences significant side effects of Spironolactone they will be switched to Epleronone in line with clinical care.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-08-31
Completion
2030-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539259 on ClinicalTrials.gov