Aortic StenosisPhase 2RELIEF-ASNCT07539259

Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis

A Phase 2 study testing Dapagliflozin (DAPA), Spironolactone (drug) and Spironolactone + Dapagliflozin in people with Aortic Stenosis, run by University College, London.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Stenosis
What is being tested?: Dapagliflozin (DAPA), Spironolactone (drug) and Spironolactone + Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 445 participants
Where: No sites listed yet
Study dates: Dec 2026to 28 Feb 2030
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants ≥ 18 years
Left Ventricular Ejection Fraction (LVEF) ≥40%.
Diagnosed with severe symptomatic aortic stenosis* by a cardiologist or cardiac surgeon.
o Severity of AS follows international guideline criteria [38], 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. including severe low flow low gradient AS
Referred for surgical or transcatheter AVR (SAVR or TAVI).
Able to provide informed consent and comply with study procedures.

Who cannot join

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
Concomitant severe other valve lesion (severe MR, MS or AR)
Contraindications to MRAs including:

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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 or with a history of diabetic ketoacidosis
Type 1 or Type 2 Diabetes on insulin.
Concomitant diagnosis affecting trial participation or life expectancy of less than two years as evaluated by the treating clinician.
Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet local safety rules for MRI). NB: Conditional pacemakers/ICDs, if implanted after the baseline scan, are not an exclusion, depending on local expertise.
Ongoing participation in another CTIMP interventional clinical trial (i.e. drug trial), will not be permitted. Participation in any other trial will need to be discussed with the trial investigators.
Significant comorbidities that would contraindicate participation, including uncontrolled hypertension, or recent myocardial infarction (within 3 months prior to screening).
Pregnancy or breastfeeding, or females of childbearing potential not using an effective method of contraception.
Any other medical or psychiatric condition that would interfere with participation or compliance with study procedures as determined by the Principal Investigator (PI).
As evidenced by features of decompensated cirrhosis e.g. hepatic encephalopathy, ascites, jaundice or markedly deranged liver blood tests e.g. elevated bilirubin, serum albumin <30 or deranged clotting

About this study

Official title: Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial

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
Being tested: Dapagliflozin (DAPA), Spironolactone (drug), Spironolactone + Dapagliflozin, Epleronone
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07539259
Study group	Role	What they receive
Dapagliflozin	Active comparator	One tablet of Dapagliflozin once a day for the duration of the trial - 12 months Receives: Drug: Dapagliflozin (DAPA)
Spironolactone	Active comparator	One tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks). Receives: Drug: Spironolactone (drug); Drug: Epleronone
Dapagliflozin and Spironolactone	Active comparator	one tablet of Dapagliflozin and one tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks). Receives: Drug: Spironolactone + Dapagliflozin; Drug: Epleronone
Standard of care	No intervention	Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the left ventricular mass indexed from pre Aortic Valve Replacement (AVR) to 12 months post AVR
Left ventricular mass indexed (LVMi) measured by cardiac MRI in g/m^2.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 202628 Feb 2030

First posted20 Apr 2026
Study startDec 2026 (estimated)
Primary completionAug 2029 (estimated)
Study completion28 Feb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
More trials run by University College, LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 445 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07539259
Sponsor's protocol ID: 181443
Other IDs: NIHR170907
Acronym: RELIEF-AS
Status last verified: Sep 2026
First submitted: 13 Apr 2026
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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