Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis

ConditionAortic Stenosis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity College, London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥ 18 years

Left Ventricular Ejection Fraction (LVEF) ≥40%.

Diagnosed with severe symptomatic aortic stenosis* by a cardiologist or cardiac surgeon.

Referred for surgical or transcatheter AVR (SAVR or TAVI).

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

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.

Treatment groups

445 Participants

are divided into 4 treatment groups

Group A: DapagliflozinActive comparator 1 intervention

Group B: SpironolactoneActive comparator 2 interventions

Group C: Dapagliflozin and SpironolactoneActive comparator 2 interventions

Group D: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: