To Establish Whether Dapagliflozin and Spironolactone in Patients With Severe Aortic Stenosis Und… (NCT07539259) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
445 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants ≥ 18 years
* LVEF ≥40%.
* Diagnosed with severe symptomatic AS by the clinical care team.
o Severe AS defined according to international guideline criteria, namely at least one out of: effective orifice area \[EOA\] \<1.0 cm2, indexed EOA of 0.6 cm2/m2, peak velocity \>4.0 m/s or mean gradient \>40 mmHg.
* Referred for surgical or transcatheter AVR (SAVR or TAVI).
* Able to provide informed consent and comply with study procedures.
Exclusion Criteria:
* 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
* Contraindications to MRAs including:
* Addison's disease.
* Acute porphyrias.
* Receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP 3A4 (for example. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).
* Contraindications to SGLT2-inhibitors including:
* Active urinary tract infections.
* At risk of diabetic ketoacidosis (e.g. Type 1 diabetes mellitus)
* Concomitant diagnosis affecting trial participation or life expectancy of less than two years.
* History of significant arrhythmias or other cardiac conditions that would interfere with the trial outcomes.
* Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the left ventricular mass indexed from pre Aortic Valve Replacement (AVR) to 12 months post AVR