Heart drugs may boost recovery after valve surgery
NCT ID NCT07539259
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests whether two heart failure medications, dapagliflozin and spironolactone, can help the heart recover better after aortic valve replacement. About 445 adults with severe aortic stenosis will take one or both drugs daily for 12 months. The goal is to see if these medicines reduce heart muscle thickness and scarring, improving long-term heart function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 445 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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 * Concomitant severe other valve lesion (severe MR, MS or AR) * 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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