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Heart drugs may boost recovery after valve surgery

NCT ID NCT07539259

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 445 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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