Phase 2 Dapagliflozin Spironolactone Aortic Valve Replacement Trial
ClinicalTrials.gov Studies
Summary
NIH registered a Phase 2 randomized controlled trial (NCT07539259) evaluating dapagliflozin and spironolactone in patients with severe aortic stenosis undergoing aortic valve replacement. The four-arm trial will assess whether these heart failure medications improve left ventricular mass regression, myocardial health, and patient-reported outcomes compared to standard-of-care alone over 12 months.
“This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who have their valve replaced through aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.”
What changed
NIH registered a new Phase 2 clinical trial on ClinicalTrials.gov involving dapagliflozin and spironolactone as interventions for patients with severe aortic stenosis undergoing aortic valve replacement. The trial has four treatment arms including each drug as monotherapy, combination therapy, and standard of care, with participants receiving study medication for 12 months.
Healthcare providers and clinical investigators involved in cardiovascular care or heart failure management may encounter patients enrolled in this trial. The trial focuses on left ventricular mass regression as the primary outcome, with secondary assessments of myocardial health and patient-reported outcomes. Trial sponsors and clinical sites should ensure appropriate safety monitoring, particularly for the spironolactone arm which includes an additional safety follow-up visit.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Randomised Controlled Trial 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 Than Standard-of-care Therapy Alone.
Phase 2 NCT07539259 Kind: PHASE2 Apr 20, 2026
Abstract
This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who have their valve replaced through aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.
In many patients even after an AVR, the heart still is 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 patients having an AVR recover better. It will assess two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS. We hope that 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: Dapagliflozin (DAPA), Spironolactone (drug), Spironolactone + Dapagliflozin, Epleronone
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